Career Opportunities

Career Opportunities


Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by our goal of improving the lives of people living with cancer. We pursue this goal with a tenacity, focus, and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking, intelligent, thoughtful, and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the lives of patients.


Reports To:

Associate Director, Accounting

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Managing and overseeing the daily accounting operations of the finance department. Responsible for month-end close activities, analyzing accounting data, executing and maintaining policies and procedures. Work closely with a cross-functional team and effectively communicate to ensure completion of tasks.

Roles and Responsibilities of the Position*

  • Manage the month-end, quarter-end and year-end accounting close process and ensure close process is performed in a timely and accurate manner
  • Perform month-end close activities related to major balance sheet accounts such as Payroll, Related Benefits, Accrued Expenses, including Clinical Trial Accruals
  • Prepare and post journal entries and prepare account reconciliations
  • Work directly with HR and Payroll Service to perform payroll activities
  • Record all payroll entries necessary and complete reconciliations
  • Responsible for recording accruals related to bonus and PTO along with reconciliations
  • Design and maintain clinical trial accrual models in MS Excel
  • Liaise with multiple departments, CROs, and vendors monthly regarding:
  • overall progress of clinical trials to budget,
  • completion of work at period end by CROs, labs, and other vendors, and
  • number of patient visits completed, and site costs incurred
  • Collaborate with clinical operations and contracts to gain an understanding of drafted contracts and work orders for planned projects
  • Analyze invoice data and compare to budget, contracts, and work orders to derive needed accruals or prepaid expenses at each period end
  • Update budgets and forecasts and provide budget vs actual analysis for areas of responsibility
  • Review posted vendor invoices for accuracy of input
  • Support internal and external audit requirements related to specific areas of responsibilities and prepare supporting documentation for SEC filings as needed
  • Assist in maintaining corporate accounting policies and procedures

Required Qualifications and Background

  • Bachelor's degree in Accounting or Finance
  • 4+ years relevant professional experience is required (mix of private and public experience preferred)
  • Pharmaceutical or biotechnology industry experience is required
  • Intercompany transactions and reconciliations experience a plus
  • Clinical trial activity, modeling and accrual process experience is a plus
  • CPA is preferred
  • Strong understanding of U.S. GAAP accounting and reporting and SOX requirements
  • Strong analytical, problem solving, organizational & project management skills
  • High degree of dedication to improvement and strong sense of ownership
  • Team player, with the ability to work independently and willingness to take on challenges in dynamic environment
  • Excellent written and verbal communication skills, including ability to interact effectively with management team, peers, cross-functional teams and business partners
  • Extensive knowledge and use of Microsoft Excel
  • Experience with SaaS ERP and P2P systems

Physical Demands / Travel

The physical demands of this job are consistent with working in an office/lab. Travel expected to be around 25%.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office/lab.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Executive Director, Safety Operations

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Associate Director, Drug Safety is responsible for pharmacovigilance activities involving the Company's products and/or clinical trials. The Associate Director, Drug Safety will manage individual adverse events (AE) cases, including review, processing and evaluation of safety reports.  Additional duties include participating in the safety surveillance program for investigational products and assisting with the responsibility of managing technical functions at a cross functional level.

Roles and Responsibilities of the Position*

  • Oversee the proper and timely collection and reporting of AE information from all sources.
  • Assist in the preparation and management of aggregate safety reports (e.g. IND safety reports, DSURs, PSLLs etc.).
  • Perform medical review of AEs/SAEs from clinical trials, interfacing with reporters as needed.
  • Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, ICFs, CSRs, IBs and other documents as needed.
  • Review of protocols, case report forms, guidelines, CSRs and manuscripts as requested.
  • Assist with the development and maintenance of pharmacovigilance related SOPs, policies and work instructions.
  • Create and track case processing metrics for internal monthly safety reports.
  • Contribute to regulatory authority submissions by reviewing safety data and assisting in the preparation of relevant sections.
  • Participate in regulatory and inspections/audits as it relates to pharmacovigilance activities.
  • Collaborate cross functionally with other departments including clinical, biostatistics, data management, clinical operations and regulatory affairs with respect to safety related issues.
  • Liaise to provide drug safety oversight of processes overseen by vendors.
  • Participate in addressing drug safety-related questions from Regulators or to support Company internally.
  • Other duties may be assigned.

Required Qualifications and Background

  • Health science degree: Nursing (RN, BSN, MSN or NP),  RPH, PharmD, PA or MD.
  • Minimum of 7 years of experience in the pharmaceutical industry or CRO, with 5 years in drug safety, pharmacovigilance and risk assessment or relevant experience.
  • Experience in the management of safety information originating from clinical trials and post-marketing sources.
  • Experience in Hematology/Oncology desired.
  • Experience and working knowledge of Good Pharmacovigilance Practices (GPvP) required.
  • Knowledge of U.S. and International Regulatory Reporting Requirements for Product Safety, and of the clinical development process.
  • Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for both clinical trial and post-marketing environments.
  • Ability to interpret scientific and clinical trial data.
  • Strong verbal and written communications and presentation skills.
  • Proven problem solving, decision-making and interpersonal skills.
  • Detailed knowledge of drug safety databases.
  • Expertise working with MedDRA.
  • Possess strong leadership skills and the ability to compile and disseminate information to others in a cohesive fashion to assure a clear understanding of project status and direction.
  • Proficiency in MS Office Suite.
  • Strong ability to prioritize tasks and keen attention to detail.
  • Ability to be both enterprising and resourceful.
  • Proven ability to work on multiple projects in a fast-paced environment.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, Regulatory CDx

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Associate Director, Regulatory, CDx will provide project oversight and regulatory submission support for biomarker and diagnostic technologies for the Loxo Oncology at Lilly pipeline, in addition to supporting program management  for diagnostics projects. Supporting Companion Diagnostic (CDx) development plans, the successful candidate, in collaboration with both Diagnostic (Dx) and Drug (Rx) development teams, will advise on the managing the CDx partners and CROs developing diagnostic assays, coordinating transfer of materials and knowledge as well as collaborating with partners towards timely CDx regulatory submissions in a small fast-paced, dynamic work environment. In addition, he/she will assist/advise in managing the development, outsourcing, and validation of clinically applicable biomarker assays. This function will play a critical role in R&D, with emphasis on later stage diagnostic development associated with Loxo Oncology at Lilly’s programs. This individual must perform with a high degree of independence and will work directly on programs as an  established regulatory expert in CDx development.

Roles and Responsibilities of the Position*

  • Responsible for planning and executing meetings with regulatory agencies that include diagnostic partners and internal Dx and Rx teams.
  • Work with Rx regulatory colleagues and diagnostic partners to determine best practices towards development & global registration activities.
  • Evaluate impact of relevant Rx and CDx regulations on Rx and CDx development & registration activities, respectively.
  • Provide project management/oversight towards CDx regulatory deliverables (e.g. SRD, IDE, CDRH pre-subs, PMA, 510(k)), technical feedback on CDx analytical and clinical study plans, regulatory support, strategic guidance and advisement on CDx project teams.
  • Help develop strategies to enable timely registration and approval of diagnostic products by regulatory agencies, synchronizing with the therapeutic development plan.
  • Provide leadership and support interactions with diagnostic partners to mutually align on co-development regulatory needs and expectations for major project tasks like regulatory pre-market approval (e.g. PMA, 510(k), EU technical files and international registration deliverables) submissions.
  • Support team or lead interactions with FDA/CDRH and other health authorities (HA).
  • Generate SRD and CDRH pre-subs as needed to support Rx Clinical Strategies
  • Review and approve key regulatory submissions to CDRH generated by CDx partners.
  • Help with clinical biomarker data and CDx samples in collaboration with the biomarker/biospecimen team.
  • Generate CDx regulatory team meeting schedules, agendas and meeting minutes.
  • Support Dx teams on contracts, budgets, project and development timelines.
  • Maintain knowledge of applicable CDx regulatory requirements and scientific/technical issues relevant to assigned projects.
  • Work with Rx regulatory team members to align all CDx regulatory project activities and deliverables from each functional area.
  • Support the development and maintenance of high level, detailed CDx timelines to assure that the functional timelines are aligned with global program timelines.
  • Bring issues to Manager or Program team’s as necessary and participate in the resolution of delays or potential delays.
  • Manage project team meetings as well as minutes, agendas, action items, etc.
  • Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre- clinical, clinical or commercial).

Required Qualifications and Background

  • B.S. degree or higher, preferably in a health-related field. Advanced degree strongly preferred.
  • Minimum of 3 years of late stage CDx development and regulatory experience at a diagnostics or pharma company.
  • Prior CDRH pre-submission, SRD, PMA experience required.
  • NGS assay development/regulatory experience preferred.
  • Familiar with regulatory issues and challenges associated with drug/diagnostic co-development and companion diagnostics.
  • Knowledge of FDA or international HA guidance documents or guidelines relevant to CDx development/registration.
  • Experience with Japan, China, South Korea CDx registration a plus.
  • Well-developed Regulatory project management execution, communication, and presentation skills.
  • High level of integrity, accuracy, and attention to detail.
  • Self-organized, self-directed, highly motivated with strong critical thinking and analytical skills.
  • Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
  • Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.
  • Outstanding interpersonal, communication and negotiation skills.
  • Demonstrated ability to guide/coach teams to timely achievement of objectives.

Physical Demands / Travel

The demands of this position are consistent with light office duties. This position is required to travel approximately 15%.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Biospecimen Manager

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Biospecimen Coordinator will be responsible for tracking inventory and overseeing the downstream processing of oncology research and clinical biomarker samples.  This individual collaborates with oncology clinical study teams and research teams including Clinical Trial Managers (CTMs), Data Managers, and a network of contract research labs. 

Roles and Responsibilities of the Position*

  • Utilize software tools to track inventory of oncology research and clinical biomarker samples
  • Maintain accurate and concise inventory of research and clinical/preclinical oncology biomarker samples across drug programs and third-party labs
  • Support clinical development teams to design biospecimen handling logistics with preferred vendors
  • Maintain regular metrics of biospecimen activities for studies
  • Track and resolve discrepancies with study team, sites, or CRO vendors within specified time frames
  • Assist in developing biospecimen collection plans with vendors by aligning with the clinical study protocol for sample collection requirements
  • Use monitoring tools to proactively identify trends and provide feedback to internal departments
  • Oversee shipments of biomarker samples from sample repositories to third party labs for testing

Required Qualifications and Background

  • Bachelors’ degree in Life Sciences, health related field or equivalent experience
  • Minimum of 3 years sample management experience in pharmaceuticals, laboratory, or biorepository setting
  • Oncology experience required across all phases of clinical trials
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines.
  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.
  • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email.
  • Excellent organizational skills with high attention to detail is required
  • Strong computer skills (spreadsheets, word processing, etc.) is required
  • Experience using sample management database is preferred
  • Ability to manage, prioritize, and routinely report progress on multiple projects and tasks

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, Biostatistics

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position will serve as study statistician for Phase 1-3 oncology studies to support NDA submissions as well as coordinating activities with other functional groups to ensure timeliness and quality of study deliverables. 

Roles and Responsibilities of the Position*

  • Assist data management staff in the design of case report forms; review of study database structures, data management plan, edit check specifications, and manual data review listing specifications; write additional data check specifications.
  • Develop and review statistical analysis plans, including the definitions of derived variables, structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports.
  • Direct and conduct statistical analyses and interprets results of analyses for assigned studies. Maintain consistent analytical approaches and reporting formats within and across studies.
  • Understand and utilize SAS as well as other statistical software packages. As needed, write programs to select/retrieve/manipulate/edit/analyze data.
  • Responsible for the accuracy and completeness of statistical analyses conducted for assigned studies. Research and apply new statistical procedures as needed.
  • Prepare statistical summary reports as needed. Write and/or review the statistical sections of protocols and clinical study reports. Review draft protocols and clinical study reports.
  • Document and archive analysis and programming work to ensure a complete audit trail. Create and maintain biostatistics files for each assigned study.
  • Establish and maintain effective working relationships with vendors and study teams, including data management personnel, statistical programmers, clinical research personnel and corporate partners.
  • Participate in study meetings as needed.

Required Qualifications and Background

  • MS or PhD in Statistics/Biostatistics or related field with 0-2 (with PhD) or 1-3 (with MS) years of experience in biotech/pharmaceutical industry or medical research setting as a statistician or statistical analyst
  • Oncology experience is highly preferred
  • Ability to work effectively in a cross-functional team setting
  • Able to collaborate effectively with internal and external study teams to meet project timelines.
  • Good interpersonal and project management skills are essential.
  • Excellent written and oral communication skills

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, Bioassay Screening

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Cell Biologist will be responsible for identifying, developing, and performing robust, reproducible cell assays to support drug discovery and development in a team environment. The Cell Biologists will provide hands-on compound testing to support the small molecule drug discovery oncology pipeline. The scientist fulfilling this position will be responsible for characterizing the effects of small molecule compounds on specific protein targets in cells using multiple plate-based assay formats examples include HTRF, ELISA, In-Cell Western, Mesoscale, and proliferation. A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.

Roles and Responsibilities of the Position*

  • Cell Culture Expertise
  • Develop robust cell-based assays
  • Design, execute, and trouble-shoot experiments
  • Experience in the following assay formats: HTRF, ELISA, In-Cell Western, Mesoscale, and Chemiluminescence 
  • CRISPR and Cloning experience is a plus.
  • Perform comprehensive data analysis
  • Communicate experimental findings to team members
  • Operate, implement and troubleshoot laboratory automation
  • Actively engaged in advancing drug discovery programs 
  • This is a “hands-on” laboratory, based position.

Required Qualifications and Background

  • BS/MS in biology, biochemistry or related fields
  • 2+ years of experience culturing cells and performing cell assays
  • A scientific foundation in the understanding and implementation of a wide range of cell-based screening assays and readouts
  • Excellent oral and written communication skills including experimental documentation
  • Works well with team members daily across functional areas
  • Continual learner who works independently and possesses a can-do attitude
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Highly organized with exceptional attention to detail
  • Proficient in Microsoft Office suite and applications

Additional Preferred Qualifications

  • Experience in biotech or pharma environment
  • A scientific foundation in the understanding and implementation of a wide range of cell-based screening assays and readouts
  • Excellent oral and written communication skills including experimental documentation
  • Works well with team members daily across functional areas
  • Continual learner who works independently and possesses a can-do attitude
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Highly organized with exceptional attention to detail

Physical Demands / Travel

The physical demands of this job are consistent with a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director/Associate Director, Clinical Operations

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Clinical Contracts Specialist help support the negotiation and finalization of master agreements, clinical trial agreements, general services agreements, consultancy agreements, lab services, and amendments for Investigators, clinical sites and vendors in support of Clinical Operations. This role requires the ability to solve complex problems that require ingenuity, innovation, and creativity as well as experience working with clinical research phases I-IV. The ability to collaborate with other clinical contracts team members, clinical trial teams, study start-up groups, investigational sites and vendors to verify and develop budget and negotiate cost savings is imperative. 

Roles and Responsibilities of the Position*

  • Support the negotiation and execution of agreements and budgets including but not limited to master agreements, clinical trial agreements, general services agreements and amendments.
  • Collaborate with clinical contract team, clinical trial teams and other internal stakeholders, study start-up groups, investigational sites, and vendors to support the delivery of fully executed contracts in support of timely study start-up to meet departmental and organizational goal to meet departmental and organizational goals.
  • Assist with the formulation of request for proposals (RFP) for clinical services including bidding process and scope of work (SOW).
  • When required, act as liaison between clinical service groups (SMO, CRO), legal and clinical trial teams for outsourced trials.
  • Contribute to negotiation efforts to resolve complex and “deal breaker” issues with external parties.
  • Support the development of contract concepts and techniques and solves complex contractual problems that require ingenuity, innovation, and creativity. 

Required Qualifications and Background

  • B.S. degree in business administration, finance, science or related field or equivalent on the job experience may be considered; advanced degree a plus.
  • Minimum 3-5 years of experience in pharmaceutical services with 2+ years of contract management and/or study start-up activities including contract negotiations and management.
  • High degree of organizational, analytical, and team management skills.
  • Ability to handle complex budgets.
  • Computer literacy with document and spreadsheet applications.
  • Ability to work on complex, multi-faceted projects.
  • Proven negotiation skills and vast knowledge of clinical trial agreements. 
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Strong collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome any inefficiencies.
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Associate Director, Clinical Scientist

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to participate in the entire spectrum of the drug development process. We design our drugs “from the ground up”, starting with the selection of a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target.  In your role, you will have the opportunity to move this drug “from the bench to the bedside”, from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval. You will participate directly in improving the lives of people fighting their cancers.

Roles and Responsibilities of the Position*

In your role, you will team with the medical monitor and other team members to design, implement execute and analyze results for Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as you will interact with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.

We are a small company, but we are highly focused on clinical and regulatory execution. As a key member of our team, you will have the opportunity to work and learn in a fast-paced, team-oriented and exciting work environment that will literally change the lives of cancer patients for the better.

The Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring of clinical development programs. These programs include early proof of concept through registration in a variety of targets and may involve collaborations with corporate development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities. 

  • Serve as the clinical science representative on global and regional clinical execution teams.
  • Create and foster strong strategic partnerships with colleagues that include Clinical Operations/Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management, Drug Safety, Translational Medicine, and pre-Clinical Development. 
  • Lead the design and interpretation of clinical trials. 
  • Assist in the writing and/or development of protocols, informed consent forms, case report forms, Statistical Analysis Plans, Data Management plans, clinical study reports and regulatory-related documents.
  • Assist in the development of abstracts, manuscripts, study/program design and presentations; collaborate with external consultants as needed.
  • Review, interpret, and present clinical data from development program and the relevant literature at relevant scientific meetings.
  • Support the writing of subsequent regulatory briefing documents.
  • Lead and accountable for interpretation of interim data analyses, detailed clinical data review, and preparation of dose escalation meetings.  
  • Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
  • Along with Clinical Operations, work closely and liaise regularly with clinical sites and investigators to oversee study enrollment and success in clinical trials
  • Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
  • Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
  • Proactively generate ideas for improvements and take action to solve problems and achieve goals beyond what is required.

Required Qualifications and Background

  • PhD, PharmD, NP, or MD
  • The ideal candidate will have 5 years of biopharma experience in an academic or industry setting and at least 2+ years’ medical/clinical scientist experience in oncology. At least 5 years’ clinical research experience preferred, particularly in drug development in oncology.
  • Clinical trial expertise along with experience in oncology with drug development highly desirable. Must possess a strong background in clinical trials in an academic or industry setting.
  • Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.
  • The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.
  • The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor appearance, and integrity. Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, Computational Chemistry

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Loxo Oncology at Lilly Discovery group’s mission is to invent and advance life-changing oncology drugs for cancer patient populations that are poorly treated by existing therapies. To that end, we are building a multi-disciplinary team of dedicated discovery scientists that are passionate about driving the science forward to create and advance highly selective drugs for known oncogenic drivers. We are currently looking for a computational chemist who enjoys tackling cutting edge drug discovery problems and is well versed in the effective use of all current computational techniques and tools. The ideal candidate will be passionate about working with scientists across disciplines to invent and advance novel approaches to drug discovery. The position requires excellent people skills, a positive can-do attitude and the ability to thrive in a highly interactive, fast-paced, team environment.

Roles and Responsibilities of the Position*

  • Work closely with our multidisciplinary group on structure-based and ligand-based design and optimization of small molecule oncology drugs
  • Enable team success by employing a range of modern computational techniques including Quantitative Structural Activity Relationship (QSAR) models, homology modeling, molecular dynamics simulations, multivariate analysis, and in silico predictive models
  • Provide computational chemistry insight for new target identification and evaluation initiatives in the oncology space across a range of target and binding mode types
  • Catalyze new hit and lead discovery leaning computation insight to selection of screening collections, database mining and interpretation of results and virtual screening techniques
  • Work with on-site IT staff to administer and maintain the necessary hardware, software and other computational infrastructure to enable state of the art computational impact on oncology research programs
  • Proactively investigate new or different technologies to improve the effectiveness of the team
  • Contribute to the overall strategic thinking for the discovery organization

Required Qualifications and Background

  • Ph.D. in Chemistry or related field
  • Experience in small molecule drug discovery across a range of target types, approaches, and drug discovery strategies in a biotechnology or pharmaceutical setting is preferred
  • Possess a working understanding of medicinal chemistry, in vitro and in vivo ADME, and couple that with modeling-driven approaches that extend to aspects of lead optimization beyond potency
  • Forward thinking in terms of applying modern computational approaches to current scientific challenges. Apprised of the latest scientific breakthroughs in computational chemistry and ability to apply those techniques to good effect
  • The ideal candidate will be a key thought leader on the team with a passion for bringing creative approaches to solve challenging problems.
  • Excellent interpersonal skills with ability to communicate effectively with a multidisciplinary team, the LOXO executive team, and outside collaborators. The ability to lead the team in prioritization of activities and programs
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

The physical demands of this job are consistent with lab environment.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Clinical Trial Manager

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

CRA/Field Site Monitor will coordinate clinical studies and be responsible for all major stages of study development, execution, monitoring, and close-out. This individual will also be responsible for clinical study site maintenance, data and source documentation collection, as well as field monitoring of clinical trials. Duties will include ensuring compliance to the study protocol, and Monitoring Plan by ensuring completeness and accuracy of data as well as compliance with domestic and international regulations, Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures.

Roles and Responsibilities of the Position*

  • Drafts materials including informed consents, case report forms (CRFs), CRF completion guidelines, and technical instructions.
  • Carries out clinical site qualification, IRB/ethical committee submissions, protocol initiation, site monitoring, and site close-out
  • Coordinates and manages the activities of investigative sites to ensure compliance with study protocol requirements
  • Ensures preparation, collection and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
  • Conducts clinical site and data monitoring and completes monitoring visit reports
  • Evaluates clinical data and coordinates data query resolutions
  • Supports internal departmental quality compliance
  • Prepares progress reports and performance metrics

Required Qualifications and Background

  • Minimum of 2 years field monitoring experience
  • Oncology experience highly preferred
  • Understands and can apply knowledge of clinical trial designs to trial execution
  • Advanced knowledge and experience with GCP/ICH and local regulations
  • Experience in web-based data collection applications, knowledge of key areas of Compliance
  • Strong communication skills as single point of contact for investigator
  • Strong skills in building and maintaining relationships with investigative sites
  • Excellent organizational skills with high attention to detail is required
  • Strong computer skills (spreadsheets, word processing, etc.) is required
  • Ability to manage, prioritize, and routinely report progress on multiple projects and tasks
  • Strong presentation skills to internal professionals and external collaborators

Physical Demands / Travel

This role can require up to 25% domestic and international travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.   

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, Medical Affairs

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Diagnostics Medical Science Liaison (DxMSL) is responsible for the identification and engagement of targeted groups of regional thought leaders within the pathology, laboratory, and oncology communities with specific responsibility for providing consistent delivery of educational and compliant scientific information surrounding clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.

Roles and Responsibilities of the Position*

  • Identify and develop relationships with clinical/community/academic thought leaders on a local and regional level.
  • Serve as Loxo Oncology’s scientific representative to the Pathology, Diagnostic and Medical communities and facilitate the appropriate exchange of scientific information.
  • Utilize approved resources to address inquiries, ensuring they are in compliance with all guidelines and regulations.
  • Communicate diagnostic and therapeutic market trends which may impact biomarker/genomic testing.  
  • Participate and support advisory boards and steering committees.
  • Lead and/or participate on committee/project teams which support Diagnostic MSL strategies as delegated by MSL leadership. 
  • Attend identified relevant national/regional/local education meetings and conferences, maximizing opportunities at these events.
  • Develop and implement educational speaker programs for the pathology/lab audience.
  • Educate on high quality comprehensive testing for relevant biomarkers in precision oncology and make ties to Loxo pipeline assets.

Required Qualifications and Background

  • Advanced doctoral degree strongly preferred (e.g. PharmD, MD, DO, or PhD). Candidates with a diagnostic laboratory and or clinical pathology background (e.g. MSN, PA) and extensive hematology/oncology MSL experience will also be considered.
  • 0-3+years’ MSL experience in Oncology or Oncology Diagnostics required
  • Ability to establish and maintain relationships with influential thought leaders.
  • Product launch experience a plus; Laboratory or Clinical Diagnostics experience beneficial.
  • Exceptional interpersonal skills.
  • Ability to excel in dynamic settings with short timelines.
  • Strong written/verbal communication and presentation skills.
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

Please note this role will require up to 50% travel, primarily within assigned region but also nationally and globally as required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is remote based, with significant travel on a regional basis to various sites.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Head, CMC

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s chemical manufacturing controls (CMC) team has an immediate opening for a Director of CMC. The individual will be responsible for leading and coordinating research and manufacturing operations at external research, development, and manufacturing organizations (CDMOs). Responsibilities will include ensuring that current GMP standards are implemented for the production, testing and control of manufactured drug substance and/or drug products.

Loxo Oncology at Lilly is looking for an independent self-starter with experience designing successful drug substance routes and manufacturing under cGMP.  This individual will be responsible for the preparation of technical reports and drug substance sections of CMC regulatory submissions.

Roles and Responsibilities of the Position*

  • Manage activities at drug substance CDMOs. Interact with contract site management and staff (may include being on site)
  • Manage the manufacture of drug substance for toxicology studies, clinical trials, and commercial supply at CDMOs, including review and approval of GMP documentation:
    • Process development and stability protocols, methods and reports
    • Change documentation
    • Master and executed drug substance batch records
  • Proactively manage risks/capability and develops mitigation plans. Identify and communicate risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship
  • Prepare RFPs and technical packages for the procurement of starting materials and GMP drug substance manufacturing campaigns.
  • Oversee the development of appropriate analytical testing methods for drug substance
  • Author and review technical documents, development reports, and drug substance CMC sections for IND, IMPD and global marketing applications
  • Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel
  • Work with QA to prepare drug substance release and stability specifications and provide technical guidance for on-site audits

Required Qualifications and Background

  • Ph.D. in organic chemistry or related discipline with 10+ years experience, or Master’s with 12 years of experience, or a Bachelor’s degree with 15+ years pharmaceutical industry experience and a minimum of 8 years in a process chemistry route development organization
  • Excellent scientific knowledge of process chemistry
  • A proven track record of developing and improving process routes for GLP and GMP manufacturing.
  • Prior manufacturing experience, including management of Contract Manufacturing Organizations.
  • Knowledgeable in good manufacturing practices for the preparation of drug substance for clinical studies and commercial supply
  • Experience in drafting drug substance CMC sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong written and oral communication skills
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Detail oriented and well organized
  • Good and thoughtful listener
  • Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position requires occasional travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office with some traveling in the field.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

VP, Small Molecule Biology

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Director, Mechanistic Biology will be responsible for guiding the research of a mechanistic biology team focused on understanding protein-protein and protein-small molecule interactions utilizing biochemical and biophysical methods and techniques. The mechanistic biology team will work on multiple drug discovery project teams to provide rapid rigorous mechanistic characterizations to differentiate the activities of small molecule compounds, advance novel drug targeting strategies, develop specialized assays for drug discovery project teams, understand drug resistance, and evaluate new targets. The mechanistic biology team will work closely with other project team members across disciplines including structural biology, cell biology, translational biology, in vitro pharmacology, and medicinal chemistry.

Roles and Responsibilities of the Position*

  • Supervise and mentor biochemists and biophysicists engaged in Loxo Oncology at Lilly discovery projects to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
  • Actively participate in the team’s research activities (i.e. hands-on experimental work, experimental design, advanced analysis, etc.).
  • Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our discovery, clinical and research programs.
  • Proactively investigate new or different technologies and methods to advance our discovery projects.

Required Qualifications and Background

  • PhD in Biochemistry, Chemistry, Molecular/Cellular Biology or related field with 12+ years hands-on biochemistry or biophysics experience in a biotech/pharma setting OR BS/MS in Biochemistry, Chemistry, Molecular/Cellular Biology or related field with 12+ years hands-on biochemistry or biophysics experience in a biotech/pharma setting.
  • Demonstrated experience supervising 2 or more scientists required.
  • Strong background in enzymology and experimental curve-fitting and statistics.
  • Proven track record in design and development of state-of-the-art biophysical methods including, but not limited to; Surface Plasmon Resonance (SPR), Isothermal Titration calorimetry (ITC), Protein small molecule binding/activity assays, mass spectrometry, and protein/protein interaction analysis. 
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Committed to staying current with the latest scientific breakthroughs in the targeted oncology field from target identification through human clinical trials.
  • Good and thoughtful listener who values collaboration.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

The physical demands of this job are consistent with work in a laboratory setting. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

SVP, Small Molecule Discovery

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly has an immediate opening for an experienced Director of Medicinal Chemistry. The Loxo Oncology at Lilly Drug Discovery team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for accomplished medicinal chemistry professional with a proven track records of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to guide a team of Medicinal Chemists in solving medicinal chemistry challenges and will excel at working closely with scientists across disciplines. The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.

Roles and Responsibilities of the Position*

  • Lead one or more teams of medicinal chemists to drive drug discovery programs from inception to candidate nomination.
  • Empower the medicinal chemists on the team to develop a deep expertise and practical knowledge in all aspects of medicinal chemistry design including structure-based design, multi-variant SAR analysis, selectivity optimization, ADME and PK optimization, and developing robust IP positions. Apply sound scientific methods to propose hypotheses and determine next steps.
  • Apply strategic thinking to advance projects quickly by employing the right strategic focus to solve the unique challenges each project presents.
  • Grow the chemistry team to be highly effective in reducing ideas to practice by employing a broad range of modern organic chemistry transformations, synthetic methods, purification, and characterization techniques.
  • Expand the group’s productivity by effectively leading CRO relationships and proactively investigating new or different technologies to improve the -efficiency of the drug discovery process.
  • Collaborate closely with the other Discovery disciplines to enable project success. Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
  • Champion bringing new classes of targets or new modalities of target inhibition (e.g. degraders) to expand the breadth of our portfolio.
  • Communicate often and well with translational and clinical groups to develop and refine clinically informed, mechanistically grounded Target Product Profiles with a high confidence in providing drugs candidates meaningful benefits to patients.
  • Present project updates that clearly convey progress and challenges to Loxo Leadership and Scientific Advisory Boards in formal and informal settings.
  • Contribute the business development evaluation of in-license opportunities.
  • Synergize with other Loxo Oncology at Lilly leaders on identifying and advancing new targets into the portfolio.  

Required Qualifications and Background

  • A passion for making drugs that can provide a real benefit for patients.
  • Deep expertise in leading small molecule drug discovery programs in a biotechnology or pharmaceutical company setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Direct management experience leading medicinal chemistry teams.
  • An advanced degree (M.S. or Ph.D.) in synthetic organic chemistry and 12+ years of relevant experience.
  • An excellent leader and team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.
  • Strong passion for growing the organization’s talent and capabilities to stay abreast of new technologies and tackle new targets with the single-minded focus on helping patients.  

Physical Demands / Travel

The physical demands of this job are consistent with working in a lab and an office.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab and an office.   

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Executive Director, Medical

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Drug Safety Physician will lead and support the expansion of clinical development programs (or one large, complex program) in support of the overall product development plan with a focus on development of the safety profile. This physician will serve as an ambassador and resource to various physicians and clinical trial sites, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo Oncology at Lilly customers, markets, business operations, and emerging issues, and perform other responsibilities as requested.

Roles and Responsibilities of the Position*

  • Primary responsibility for daily safety case review and will contribute to the design, analysis, interpretation, and reporting of safety findings within a program and will review and contribute to the content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.
  • Primary responsibility for reviewing safety data periodically and on an ongoing basis to ensure quality control (QC) as required by program needs   
  • May participate in or lead review of protocol deviations (PD) which may impact patient safety as required by program needs
  • May participate in, or lead safety development contributions to, due diligence or other business development activity.  As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
  • Actively solicits opinion leader interactions related to the disease area(s); partners with Clinical leads, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Safety Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic and safety area. May represent Loxo at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May serve as a safety representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures, organization policies and to all other quality standards in conducting research. 

Required Qualifications and Background

  • MD, Board certified or eligible; PhD advantageous.
  • At least 2 years of oncology experience strongly preferred.
  • Ability to exercise judgment and address complex problems and create solutions for one or more projects.
  • Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
  • Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
  • Proven ability to interact externally and internally to support a global scientific and business strategy.
  • Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and appearance and an excellent written and verbal communicator.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This role will require 10-20% travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s primary work environment is in an office / traveling in the field to both US and International locations as indicated.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, Drug Safety

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Drug Safety Specialist will be responsible for providing Drug Safety/Pharmacovigilance support for new and ongoing clinical trials including the collection, processing, and reporting of adverse events/endpoints while adhering to International Council for Harmonization (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines, data protection guidelines and study procedures. 

Roles and Responsibilities of the Position*

  • Perform triage of incoming Serious Adverse Event (SAE) reports and consider assessments of seriousness, listedness, and causality; coordinate triage review with medical monitor.   
  • Review case narratives, including identifying relevant information from source documents and write/review queries when additional information needed 
  • Review data entry of SAEs in safety database including MedDRA coding
  • Coordinate medical monitor case review
  • Assist with the management of case processing deadlines
  • Assist in reconciliation between the safety and clinical databases for serious adverse events.
  • Compile safety information for aggregate safety reports and other safety related reports.
  • Assist with ongoing safety surveillance
  • Assist with compilation and updating of safety related spreadsheets including metrics and SUSAR submissions
  • Review and update existing standard operating procedures (SOPs) and assist with creation of new SOPs for safety department as indicated  
  • May oversee work performed by a safety Contract Research Organization (CRO)

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, Bioassay Screening

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Enzymology Scientist will be responsible for developing and performing robust, reproducible enzyme and binding assays to support drug discovery and development in a team environment. The scientist fulfilling this position will be responsible for characterizing the effects of small molecule compounds on specific protein targets. A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required.

Roles and Responsibilities of the Position*

  • Design, develop, and execute enzyme and binding assays in multiple formats.
  • Screen small molecule inhibitors in plated based assay formats to drive internal structure-based drug design.
  • Perform comprehensive data analysis and communicate experimental findings to the project team members.
  • Operate, implement, and troubleshoot laboratory automation.
  • Actively engage in advancing small molecule drug discovery oncology programs. 
  • This is a “hands-on” laboratory, based position.

Required Qualifications and Background

  • BS or MS in biology, biochemistry or related field
  • 5+years of experience in biochemistry, enzymology and/or assay development
  • The successful candidate is expected to have expertise in biochemistry, enzymology, and assay development
  • Experience with general biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence)
  • Experience with laboratory instrumentation and automation for medium to high-throughput screening
  • Excellent oral and written communication skills including experimental documentation
  • Works well with team members daily across functional areas
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Highly organized with exceptional attention to detail
  • Good and thoughtful listener
  • Enthusiastic, self-motivated and a continuous learner
  • Proficient in Microsoft Office suite and applications

Additional Preferred Qualifications

  • Drug discovery experience in a biotechnology or pharmaceutical setting
  • The successful candidate is expected to have expertise in biochemistry, enzymology, and assay development.
  • Experience with general biochemical and kinetic-based assay technologies (e.g. FP, TR-FRET, AlphaScreen, Luminescence)
  • Experience with laboratory instrumentation and automation for medium to high-throughput screening.
  • Excellent oral and written communication skills including experimental documentation.
  • Works well with team members daily across functional areas.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Highly organized with exceptional attention to detail.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and a continuous learner

Physical Demands / Travel

The physical demands of this job are consistent with a lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Consultant Biologist, In Vivo

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The In Vivo Technician will conduct in vivo pharmacological experiments using assays relevant to the development of therapeutics for oncology. The candidate will perform experiments and will provide technical support for studies executed within the In Vivo Pharmacology Group. The candidate will fill the AM technician role (first shift, 5:30 AM - 2:00 PM). They will assume primary responsibility for weekday morning dosing for all multiple-daily dosing studies. Candidate must be able to work independently and in close collaboration with scientific teams, multi-task effectively and operate under direct technical supervision from the department manager.

Roles and Responsibilities of the Position*

Dosing, Formulation, Lab Support, Study Implementation and Conduct (90%)

  • Responsible for morning dosing events for ongoing IVPG studies
  • Execute in vivo studies that require basic animal handling techniques for rats and mice, observation skills, tumor cell implantation, all dosing techniques (PO, IP, SQ, IM, and IV), and necropsy skills
  • Overtime dosing support of oncology studies on holidays and weekends
  • Assistance with dosing time points, formulation of IVPG compounds, and necropsy of studies conducted by other IVPG members
  • Routine lab maintenance and upkeep including but not limited to lab waste management, preparation of compound vials and gavage needles, compound ordering and maintenance of lab supplies
  • Responsible for compliance with animal care and use protocols and compliance with laboratory research and animal care and handling procedures
  • Adherence to good research practices, SOPs and notebook documentation standards

Study Analysis and Follow-Up (10%):  basic data analysis for in vivo studies

Required Qualifications and Background

  • Associate or Bachelor’s degree in animal science, biology, or related field;
  • OR 2+ years in vivo research/animal experience. Experience may be substituted for education.

Additional Preferred Qualifications

  • Some previous animal handling experience
  • Strong organizational skills
  • Excellent written and oral communication skills
  • Data analysis and record keeping skills (with attention to detail)
  • Demonstrated ability to work both independently and in a team environment
  • Ability to multi-task across diverse activities
  • Ability to adapt quickly to changes in study execution
  • Open to working assigned shift and weekend/holiday overtime

Physical Demands / Travel

0-10% travel required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, Business Operations

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager of Business Operations is responsible for negotiating complex contracts to support drug development and related biomarker needs, including sponsored research, material transfer, and collaboration agreements.  This individual will also manage the projects and relationships with partners and academic institutions arising from such agreements. 

Roles and Responsibilities of the Position*

  • Work with discovery, translational medicine, clinical, biomarker operations, legal, and finance teams to help draft, negotiate and manage contracts to support drug development and related biomarker needs
  • Identify and mitigate business risks throughout the contracting process
  • Help manage projects resulting from these contracts, including working with partners and academic institutions to track data/results as well as financial and resource obligations
  • Act as alliance manager for certain relationships

Required Qualifications and Background

  • Bachelor’s degree (MBA a plus)
  • 3+ years of business development/contract negotiation experience, preferably in the Diagnostics or Biotech/ Pharmaceutical Industries
  • Strong contract drafting, review and analysis skills
  • Alliance Management experience (or equivalent demonstration of relationship management)
  • Ability to communicate efficiently and effectively
  • Ability to manage and meet strict deadlines, work independently, and multi-task
  • Excellent attention to detail
  • MS Office skills (Outlook, Word, Excel, PowerPoint)

Physical Demands / Travel

 The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Associate Director, Clinical Data Management

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager, Clinical Data Management is responsible for leading and overseeing data management tasks from study start-up through database lock for clinical trials.  This individual works collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables follow standard operating procedures and regulatory agency guidelines. The Lead Data Manager ensures all Clinical Operations activities stay within full compliance of Loxo regulatory and legal policies.

Roles and Responsibilities of the Position*

  • Represents Data Management at study team meetings with responsibility for operational execution of DM activities
  • Executes/manages data management timelines to coordinate and synchronize deliverables with the overall study timelines
  • Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution)
  • Executes and/or distributes data management metrics, listings, and reports, as required
  • Effectively applies knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.) to data collection and DM plans
  • Collaborates and oversees CRO/service providers on assigned studies
  • Executes/manages all data management activities on assigned studies to ensure project timelines are met
  • Continually seeks means of improving processes to reduce cycle time and decrease work effort
  • Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
  • Proactively identifies potential study issues/risks and recommends/ implements solutions
  • Responsible for the accuracy and completeness of the clinical data collected during a clinical trial for all data deliverables
  • Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
  • Works with partners to increase vendor/partner efficiencies
  • Performs any and all other tasks and activities as requested

Required Qualifications and Background

  • Bachelor’s degree in life sciences, math, computer science or related field required
  • 6+ years’ clinical data management experience
  • Demonstrated leadership and project management skills
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
  • Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
  • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
  • Proven ability to work both independently and/or in a team setting
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment
  • Demonstrated ability to stay abreast of trends and new information in the profession

Additional Preferred Qualifications

  • 5+ years prior oncology/hematology experience highly desirable
  • 2+ years of Sponsor experience.
  • Recent Phase 3 registration study and submission experience preferred

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position will travel occasionally (15-20%) with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office setting.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, Finance

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager, Finance and Procurement will support the needs of our growing Discovery organization based in Boulder, CO. The Manager, Finance and Procurement, working closely with Finance and Discovery Teams,  will  help to formalize and streamline the procurement function across all areas within Discovery.  This individual will  be responsible for the planning and execution of contracting and sourcing activities, and end-to-end procurement operations as determined by Discovery team business needs. They will further be responsible for developing, recommending and implementing strategies to strengthen contract compliance and completeness, while reducing costs for the company. Additionally, this individual will provide support to the Finance team focused on forecasting, budgeting, reporting, decision support, and accounting close activities.

Roles and Responsibilities of the Position*

Procurement:

  • Partner with Discovery team and Finance to understand needs and ensure appropriate support
  • Act as the Procurement contact engaging with internal stakeholders to develop and drive execution of contracting and sourcing activities
  • Purchase order placement activities including processing of daily purchase transactions, review of appropriate classifications, price verifications, accuracy of vendor data and completeness of executed contracts to support the purchase order, in a timely manner with a processing turnaround time of 24-48 hours after requisition approval
  • Identify key vendors and organizations utilized by the Boulder Discovery team and develop sourcing strategy, including negotiation & supplier selection, and sourcing implementation
  • Prioritize, process and monitor purchase requisition queue. Review purchase requisitions for proper documentation and authorization. Actively resolve problems with incorrect requisitions. Assist employees with purchasing/contract procure to pay process and facilitate ongoing training
  • Manage all interactions for external partners supplying goods and services including contract execution, relationship management, supply ordering/inventory/tracking, interface to Coupa procurement systems, procurement data review and tracking, and vendor performance management
  • Issue purchase orders and instructions to suppliers. Provide assistance to resolve order related issues which involves working with all departments within the Company as well as outside vendors

Finance:

  • Participates in the financial planning and budgeting process, including Income Statement, Balance Sheet, molecule forecasting
  • Ensure timely delivery and accuracy of monthly and quarterly financial reporting
  • Support the annual financial planning and budgeting process
  • Ensure timely delivery and accuracy of monthly and quarterly financial reporting
  • Support the annual financial planning and budgeting process

Required Qualifications and Background

  • BS/BA is required with a strong preference for a degree in a science-related discipline
  • A minimum of 5 years of related experience in a Procurement, Business Operations, or Finance environment
  • Pharmaceutical or Biotech setting is required
  • CPA or MBA preferred
  • Experience with Coupa or other similar Procurement System
  • Experience working in a SOX and FDA regulated environment
  • Demonstrated understanding of Accounting and Accounts Payable
  • Strong verbal and written communication skills with a successful track record of presenting complex information to senior leaders and various stakeholders in the organization

Physical Demands / Travel

The physical demands of this job are consistent with working in an office/lab.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a office/lab. Travel about 30% of time.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Executive Director, Quality Assurance

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager, GLP and Biomarker Quality is responsible for all aspects of Quality Assurance supporting GLP and Biomarker Operations. The Manager Quality Assurance will establish and execute quality plans, policies and quality system elements related to GLP activities. This position will support GLP operations and the vendor management program for biomarker operations. The Manager, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance with CAP/CLIA, GLPs, GCPs, and international requirements.

Roles and Responsibilities of the Position*

  • Act as liaison across departments to proactively identify opportunities to streamline and strengthen the vendor qualification process.
  • Facilitate the qualification process for biomarker, diagnostic, and clinical laboratory vendors and represent QA at the qualification forums.
  • Maintain detailed list of GLP/clinical laboratory/biomarker/diagnostic vendors and their current status.
  • Develop SOPs that support the QA role in GLP operations.
  • Serve as QA SME when SOPs are written or revised in this area, as well as general GxP SOPs.
  • Perform a QA review of GLP toxicology reports.
  • Perform QA review of technical and regulatory documents that support clinical trials.
  • Represent QA on cross-functional clinical study teams.
  • Keeps current with global health authority laws and regulations and implements process improvements resulting from new/revised regulations or guidance.
  • Utilizes the Loxo Quality Systems to manage Quality system elements.
  • Supports external Health Authority inspections, as needed.

Required Qualifications and Background

  • Bachelor’s degree with 10 or more years of experience working in either early phase clinical compliance or clinical quality group.
  • Demonstrated knowledge in CAP/CLIA certifications and working knowledge of GLPs and GCPs.
  • Experience working with third parties, auditing, and vendor qualification.
  • Demonstrated Quality Management System experience (SOPs, training, document control, auditing, etc.).
  • Experience working in a regulated environment (e.g. FDA, EMA, etc.).
  • Self-motivated with the ability to work effectively in a dynamic environment.
  • Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization.
  • Good problem solving, written and verbal communication skill.
  • Ability to effectively manage multiple priorities with a sense of urgency.
  • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations.
  • Attention to detail and accuracy of work.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Associate Director, Regulatory Affairs

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Manager, Regulatory Affairs will provide support for one (or more) clinical programs and contribute to the execution of major submissions and responses to regulatory authorities related to IND/NDA submissions or international equivalents, Annual Reports, Clinical Protocols, Investigator’s Brochures, IND amendments for meetings with regulatory authorities as required.   

Roles and Responsibilities of the Position*

  • Responsible for supporting all aspects of regulatory submissions relevant to assigned projects or programs.
  • Assist in the coordination of meeting with health authorities and Contribute to the development of briefing packages for meetings with FDA and other global health authorities.
  • Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial).
  • Ensure completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
  • Provide review of responses and other documents intended for submission to FDA and other global health authorities as needed.
  • Prepare and compile effective presentations for external and internal audiences as needed.
    • Representing the Regulatory Affairs function on assigned cross-functional project teams and to external partners.
    • Actively participate in regulatory sub-teams and lead meetings on defined topics with a clear objective.
  • Other duties as assigned.

Required Qualifications and Background

  • BS degree required; Advanced degree advantageous.
  • Minimum 3+ years’ regulatory experience within the biotech or pharmaceutical industry within the drug development space.
  • Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements required.
  • Previous experience navigating successful submissions (INDs/NDAs) in the Oncology space is a plus.
  • Experience in interpretation and application of regulations, guidelines, policy statements, etc. strongly preferred.
  • Exposure to global regulatory requirements a plus.
  • Ability to work both independently and within project teams, to attain group goals.
  • Demonstrate strong organizational skills, including the ability to prioritize tasks.
  • Excellent oral and written communication skills.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Vice President, Medical

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Medical Director will lead the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product, scientific and business strategy.

Roles and Responsibilities of the Position*

  • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, Loxo customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and Loxo study staff. Responsibility may extend from early translational development activities to mature product lifecycle management strategies for internal and/or partnered programs.
  • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule.  Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events.
  • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.  
  • May oversee and/or be the direct manager of the work of Clinical Scientists working on the same or related programs. 
  • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Loxo at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 

Required Qualifications and Background

  • MD or equivalent required. Board Certification in Oncology or Internal Medicine preferred
  • PhD would be an advantage
  • Oncology therapeutic area knowledge required
  • At least 3-5 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent, in a medical director role.
  • Proven experience running a complex clinical research program independently.
  • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence.
  • Proven ability to interact externally and internally to support a global scientific and business strategy.
  • Extensive knowledge of phase 1-3 clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols.
  • Experience leading global regulatory interactions for preclinical, clinical and pivotal programs.
  • Prior management experience preferred.
  • Ability to exercise judgment and address complex problems and create solutions for one or more projects.
  • Ability to develop collaborative working relationships with physicians, expert consultants, and contracted vendors.
  • Strong analytical mind and problem-solving skills, attention to detail, strong organizational skills, and ability to work independently and as part of a team
  • Excellent English written and verbal communication skills. Strong document management skills, including proficiency with MS Word, EndNote, PowerPoint and Excel.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This role will require 50-60% travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a remote, home based office/office/traveling in the field to both US and International locations.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, Medicinal Chemistry

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s Drug Discovery team has an immediate opening for a Medicinal Chemist. The Loxo Oncology at Lilly team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for medicinal chemists with a proven track records of success in synthetic organic chemistry. The ideal candidate will be passionate about using synthetic chemistry and data analysis skills to solve medicinal chemistry challenges and will excel at working closely with scientists across disciplines. The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.

Roles and Responsibilities of the Position*

  • Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
  • Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. -
  • Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
  • Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
  • Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.

Required Qualifications and Background

  • B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
  • 3-5 years of experience in small molecule organic synthesis and/or drug discovery experience in biotechnology or pharmaceutical setting.
  • Proficiency in modern synthetic methodology and variable reaction scales.
  • Ability to design feasible synthetic routes to target molecules and choose appropriate reaction conditions.
  • Skilled user of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Experience in lead compound optimization for potency, selectivity, ADME and PK is preferred but not required.
  • Experience in using common synthetic chemistry software: electronic notebook, ChemDraw, Excel, literature search engines.
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.

Physical Demands / Travel

The physical demands of this position are consistent with working in a laboratory/ bench environment. Some light lifting and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a laboratory/ bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Associate Director, Medicinal Chemistry

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s Drug Discovery team in Boulder, Colorado has an immediate opening for a Medicinal Chemist.  The Loxo Oncology at Lilly team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for medicinal chemists with a proven track records of success in synthetic organic chemistry. The ideal candidate will be passionate about using synthetic chemistry and data analysis skills to solve medicinal chemistry challenges and will excel at working closely with scientists across disciplines.  The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.

Roles and Responsibilities of the Position*

  • Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
  • Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. -
  • Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
  • Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
  • Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.

Required Qualifications and Background

  • B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
  • 1-5 years of experience in small molecule organic synthesis and/or drug discovery experience in biotechnology or pharmaceutical setting.
  • Proficiency in modern synthetic methodology and variable reaction scales.
  • Ability to design feasible synthetic routes to target molecules and choose appropriate reaction conditions.
  • Skilled user of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Experience in lead compound optimization for potency, selectivity, ADME and PK is preferred but not required.
  • Experience in using common synthetic chemistry software: electronic notebook, ChemDraw, Excel, literature search engines.
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.

Physical Demands / Travel

The physical demands of this position are consistent with working in a laboratory/ bench environment. Some light lifting and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a laboratory/ bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Principal Scientist, Structural Biology

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to be part of Loxo’s discovery teams focused on creating novel, highly specific and selective drugs for genetically identified targets. The Molecular Biologist will employ modern cloning methods to support the gene-to-structure pipeline across multiple projects and project teams. This is an extremely important role where the right person will be able to have a real impact on cutting-edge science, making a real difference in patient’s lives.

Roles and Responsibilities of the Position*

  • Provide molecular biology support within a structural biology & enzymology setting.
  • Coordinate protein construct design with colleagues from varying disciplines, primarily for expression in baculovirus and E.coli expression systems.
  • Execute projects in an efficient manner, working within aggressive timelines.
  • Rapidly communicate scientific results and insights to the team.
  • Prepare reports for internal and external purposes including regulatory submissions.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
  • Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
  • Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way
  • In the future, this position’s responsibilities may include supervision of scientists and associates.

Required Qualifications and Background

  • BA/BS/MS/PhD in biology, genetics, biochemistry, molecular biology or a related field.
  • Ideal candidate will have with 5+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
  • Experience with modern cloning technologies e.g. Gibson Assembly, gBlock utilization, high throughput cloning.
  • Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast) is desirable.
  • The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Desire to cross-train and flex between sub-groups (protein expression/purification/characterization) is a must.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Experience across the gene-to-structure pipeline is a plus.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and the lab.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Principal Scientist, Structural Biology

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to be part of Loxo’s discovery teams focused on creating novel, highly specific and selective drugs for genetically identified targets. The Scientist, Protein Expression will employ modern cloning methods to support the gene-to-structure pipeline across multiple projects and project teams. This is an extremely important role where the right person will be able to have a real impact on cutting-edge science, making a real difference in patient’s lives.

Roles and Responsibilities of the Position*

  • Provide recombinant protein expression support within a structural biology & enzymology setting.
  • Execute projects in an efficient manner, working within aggressive timelines.
  • Rapidly communicate scientific results and insights to the team.
  • Prepare reports for internal and external purposes including regulatory submissions.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
  • Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
  • Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.

Required Qualifications and Background

  • BA/BS/MS/PhD in biology, genetics, biochemistry, molecular biology or a related field.
  • Ideal candidate will have with 5+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
  • Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast).  Hands-on experience of a variety of insect cell cells (SF9, SF21, T.ni/Hi5) from culture, transfection and characterization is essential.  Utilization of BIICs and TIPS is highly desirable.
  • Experience with small scale analysis of biomass, particularly regarding soluble protein expression.
  • Hands-on experience of protein purification techniques such as IMAC, SEC, IEX are desirable as is experience with the Phynexus and Akta protein purification technology.
  • SDS-PAGE, Western Blot, Cell Counter experience as well as experience of modern cloning techniques such as Gibson Assembly is a plus.
  • The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Desire to cross-train and flex between sub-groups (protein expression/purification/characterization) is a must.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Experience across the gene-to-structure pipeline is a plus.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and the lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Principal Scientist, Structural Biology

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to be part of Loxo’s discovery teams focused on creating novel, highly specific and selective drugs for genetically identified targets. The Scientist, Protein Purification will employ modern cloning methods to support the gene-to-structure pipeline across multiple projects and project teams. This is an extremely important role where the right person will be able to have a real impact on cutting-edge science, making a real difference in patient’s lives.

Roles and Responsibilities of the Position*

  • Provide recombinant protein expression support within a structural biology & enzymology setting.
  • Execute projects in an efficient manner, working within aggressive timelines.
  • Rapidly communicate scientific results and insights to the team.
  • Prepare reports for internal and external purposes including regulatory submissions.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
  • Continually advance your understanding of current methodology and new/emerging technologies by reading scientific literature.
  • Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.

Required Qualifications and Background

  • BA/BS/MS/PhD in biology, genetics, biochemistry, molecular biology or a related field.
  • Ideal candidate will have with 5+ years hands-on experience, working in a gene to structure laboratory in a biotech/pharma setting, but less experienced, motivated individuals are encouraged to apply.
  • Expertise with FPLC protein purification techniques such as IMAC, SEC, IEX, HIC is required, ideally utilizing the Akta FPLC systems.
  • Expertise with protein characterization techniques such as Mass Spectrometry (Orbitrap, QTOF, hybrid traps) and Thermal Denaturation assays such as differential scanning fluorimetry (DSF) is highly desirable.
  • Familiarity with biophysical techniques such as SPR, ITC, Fluorescent binding assays, enzyme kinetic assays is desirable.
  • Experience with a variety of protein expression systems (E.coli, BV, mammalian, yeast) as well as modern cloning technologies e.g. Gibson assembly, gBlock utilization is a plus.
  • The candidate must be self-motivated but always maintain focus on why we are here and who is important i.e. the patients and their families/caregivers.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Desire to cross-train and flex between sub-groups (protein expression/purification/characterization) is a must.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Experience across the gene-to-structure pipeline is a plus.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and the lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Principal Scientist, Translational Medicine

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

With a strong background in cancer biology, the Scientist, Translational Medicine will support lab-based translational research projects associated with Loxo Oncology at Lilly’s preclinical and early development programs. This entails independently planning and executing experiments aimed at characterizing our lead compounds, including their: (1) efficacy (in vitro and in vivo), (2) mechanism of action, (3) target patient populations, and (4) biomarkers predicting clinical response. The successful candidate will achieve these objectives by developing and executing in vitro assays, collaborating with Loxo Oncology at Lilly’s discovery scientists, and overseeing research at CROs.

Roles and Responsibilities of the Position*

  • Establish robust assays including a variety of cell-based assays (cell lines and primary cells), lentiviral transduction, enzymatic assays, ELISA, MSD, TR-FRET, Western blot, immunoprecipitation, RT-qPCR, and NGS.
  • Engineer knock-in & knockout cell lines with CRISPR and/or other technologies.
  • Execute high throughput siRNA and/or CRISPR screens of cell lines. 
  • Establish heme-oncology assays including immune cell isolation, flow cytometry, colony formation assay, and stromal cell co-culture assay.
  • Design and execute cross-assay validation studies.
  • Analyze and interpret data, with ability to troubleshoot assays.
  • Organize and coordinate multiple projects in parallel.
  • Identify, evaluate, and manage vendors for outsourced services and studies.
  • Prepare and present scientific results at congresses and in peer-reviewed journals.

Required Qualifications and Background

  • BS/MS or PhD in a biological discipline with at least 8 years of bench experience, preferably with industry experience in small molecule drug discovery programs.
  • Research experience in oncology, preferably with some exposure to heme-oncology and/or immuno-oncology.
  • Extensive experience with culturing adherent and non-adherent mammalian cell lines and primary cells using excellent sterile technique.
  • Experience with modern cloning technologies, generation of CRISPR-engineered cell lines, development of PD biomarker assays.  
  • Self-organized, detail-oriented, self-directed, highly motivated with strong critical thinking and analytical skills.
  • Willingness to work collaboratively and incorporate diverse perspectives into decision-making.
  • Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.

Physical Demands / Travel

The physical demands of this job are consistent with working in a laboratory/ bench environment. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a laboratory/bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Senior Molecular Cell Biologist will be part of the Loxo Oncology at Lilly’s Drug Discovery group in Boulder, Colorado. The Drug Discovery group is responsible for identifying molecular targets for life-changing oncology drugs, creating and evaluating novel drug candidates with a focus on small molecule drugs, and providing forward-thinking approaches to advance our clinical portfolio.  The Senior/Principal Cell Biologist will be responsible for creating and evaluating cellular assays, execution strategies to quantitatively determine the potency and selectivity of small molecule compounds and interrogate signaling pathways. The Senior Cell Biologist will have a strong understanding of signal transduction pathways and experience in designing experiments to evaluate molecular interactions and pathways. The Senior/Principal Cell Biologist will be part of the team designing, managing and evaluating in vivo pre-clinical studies. This is a hands-on position for an experienced lab scientist who enjoys working in the lab. This scientist must have excellent people skills and be able to work with a positive, “can-do” attitude in a dynamic, fast-paced, team environment focused on high quality science to deliver innovative cancer drugs.

Roles and Responsibilities of the Position*

  • Create, develop and validate quantitative mammalian cellular assays to address the project team’s mechanistic and functional needs.
  • Establish robust screening assays to support medicinal chemistry lead optimization programs. Establish processes to efficiently and effectively communicate results to the project team. 
  • Design and manage in vivo pre-clinical studies.
  • Identify, evaluate, and manage vendors for outsourced services and studies.
  • Collaborate with colleagues throughout the company to ensure assays meet the program needs and results are appropriately interpreted.
  • Prepare reports for internal and external purposes including regulatory submissions.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies. 
  • Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our clinical and research programs.
  • Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way
  • In the future, this position’s responsibilities may include supervision of scientists and associates.

Required Qualifications and Background

Required:

  • PhD in Molecular/Cellular Biology or Biochemistry, or related field with either:
    • 6+ years hands-on cell biology experience AND 2+ years work experience in a biotech/pharma setting or
    • 10+ years hands-on cell biology experience
  • OR a BS/MS in Molecular/Cellular Biology or Biochemistry with either

    • 10+ hands-on cell biology experience AND 4+ years work experience in a biotech/pharma setting or
    • 15+ years hands-on cell biology experience

Ideal candidate will also have:

  • Extensive experience in creating, developing, and running cellular assays; engineering cell lines to express or knock-down genes of interest, interrogating cellular signal transduction pathways, and characterizing kinase activity.
  • Experience with flow cytometry and general molecular biological techniques including q-PCR, ELISA, MSD and Western Blot etc.
  • Strong background in experimental curve-fitting and statistics.
  • Experience in designing in vivo animal studies.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Highly organized with excellent analytical, documentation and multi-tasking skills.
  • Committed to staying current with the latest scientific breakthroughs in the targeted oncology field from target identification through human clinical trials.
  • Good and thoughtful listener who values collaboration.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

The physical demands of this job are consistent with working in a laboratory/ bench environment. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in a lab/bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Associate Director, Clinical Science

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to participate in the entire spectrum of the drug development process. We design our drugs “from the ground up”, starting with the selection of a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. In your role, you will have the opportunity to move this drug “from the bench to the bedside”, from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval. You will participate directly in improving the lives of people fighting their cancers.

In your role, you will team with the medical monitor and other team members to design, implement execute and analyze results for Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as you will interact with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.

We are a small company, but we are highly focused on clinical and regulatory execution. As a key member of our team, you will have the opportunity to work and learn in a fast-paced, team-oriented and exciting work environment that will literally change the lives of cancer patients for the better.

The Senior Clinical Scientist will help translate preclinical discoveries into developing the next generation of cancer therapies and will be responsible for the design, implementation, and monitoring of clinical development programs. These programs include early proof of concept through registration in a variety of targets and may involve collaborations with corporate development partners. Responsibilities encompass strategic planning to ensure optimized clinical development plans for assigned projects. This person must be interested in working in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities. 

Roles and Responsibilities of the Position*

  • Serve as the clinical science representative on global and regional clinical execution teams.
  • Create and foster strong strategic partnerships with colleagues that include Clinical Operations/Development, Global Regulatory Affairs, Clinical Pharmacology, Statistics, Medical Affairs, Data Management and pre-Clinical Development. 
  • Lead the design and interpretation of clinical trials. 
  • Assist in the writing and/or development of protocols, informed consent forms, case report forms, Statistical Analysis Plans, Data Management plans, clinical study reports and regulatory-related documents.
  • Assistance in the development of abstracts, manuscripts, study/program design and presentations; collaborate with external consultants as needed.
  • Review, interpret, and present clinical data from development program and the relevant literature at relevant scientific meetings.
  • Support the writing of subsequent regulatory briefing documents.
  • Lead and accountable for interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.  
  •  Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
  • Along with Clinical Operations, work closely and liaise regularly with clinical sites and investigators to oversee study enrollment and success in clinical trials
  • Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
  • Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
  • Proactively generate ideas for improvements and take action to solve problems and achieve goals beyond what is required.

Required Qualifications and Background

  • PhD, PharmD or M.D.
  • The ideal candidate will have 5 years of biopharma experience in an academic or industry setting and at least 2+ years’ medical/clinical scientist experience in oncology. At least 5 years’ clinical research experience preferred, particularly in drug development in oncology.
  • Clinical trial expertise along with experience in oncology with drug development highly desirable. Must possess a strong background in clinical trials in an academic or industry setting.
  • Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.
  • The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.
  • The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and appearance and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, Clinical Operations

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Functions as the clinical study team leader responsible for planning and managing all operational aspects of one or more clinical studies from protocol development through database lock. Ensures timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials.

Roles and Responsibilities of the Position*

  • Responsible for the preparation and finalization of project and study- related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required
  • Responsible for the selection of investigators and study sites
  • Responsible for identifying and responding to site and study related issues and recommending corrective actions.
  • Oversee the coordination of the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT
  • Coordinate and manage Investigational Product including overall accountability and reconciliation
  • Responsible for the preparation of study budgets and timelines
  • Determine and manage project timelines and vendor performance to meet departmental and corporate goals
  • Determine and manage study budget and payment process for all clinical trial vendors including investigative sites
  • Monitor and track clinical trial progress and provide status update reports
  • Evaluate and Manage all clinical trial vendors (e.g., IVRS, central labs, and IRB)
  • Responsible for selection of CRO study staff and coordinating training including documentation
  • Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
  • Lead the planning of investigator meetings and making presentations, as required
  • Lead the review of clinical data at the CRF, data listing, and report table levels
  • Represent Clinical Operations at the Project Team level for individual studies, as appropriate
  • Partner with other research and development groups to achieve deliverables
  • Participate in Site Initiation Visits (SIVs) as required
  • Co-Monitoring of regional sites for adherence to protocol and GCP as required
  • Travel as required to carry out responsibilities
  • Identify and escalate site, vendor and study related issues to supervisor, as appropriate
  • Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
  • Potentially manage and direct activities of Clinical Trial Managers and Clinical Research Associates and if required, perform performance appraisals
  • Perform other duties as assigned

Required Qualifications and Background

  • BA/BS in related field
  • Minimum 8 years clinical drug development experience
  • Oncology and/or Hematology experience required
  • Experience in CRO selection and management, including drafting request for proposals (RFPs), bidding process, etc.
  • Experience in managing oncology clinical trials (international preferred)
  • Knowledge of FDA regulatory requirements and medical practice/techniques and terminology
  • Ability to work within a team, including leadership skills
  • Ability to organize and prioritize multiple tasks
  • Excellent communication and interpersonal skills
  • Attention to detail, organization, and problem-solving skills
  • Computer literate
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams
  • Willing collaborator
  • Strong communication skills both written and oral
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Professional demeanor and appearance and an excellent written and verbal communicator
  • Detail oriented and well organized
  • Good and thoughtful listener
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Associate Director, Clinical Data Management

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Senior Manager is responsible for leading and overseeing data management tasks from study start-up through database lock for clinical trials.  This individual works collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables follow standard operating procedures and regulatory agency guidelines. The Senior Manager ensures all clinical trial operations activities stay within full compliance of Loxo regulatory and legal policies.

Roles and Responsibilities of the Position*

  • Represents Data Management at study team meetings with responsibility for operational execution of DM activities
  • Manages a study or compound team within the DM group
  • Creates and tracks data management timelines to coordinate and synchronize deliverables with the overall study timelines
  • Generates and/or reviews/approves study documents (e.g. Data Management Plans, Case Report Forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, study protocols, UAT execution)
  • Executes and/or distributes data management metrics, listings, and reports, as required
  • Effectively applies knowledge of applicable internal, external and regulatory requirements/expectations (MHRA, FDA, ICH, GCP, PhRMA, Privacy, etc.) to data collection and DM plans
  • Collaborates and oversees CRO/service providers on assigned studies
  • Executes/manages all data management activities on assigned studies to ensure project timelines are met
  • Continually seeks means of improving processes to reduce cycle time and decrease work effort
  • Provides training on the CRF completion guidelines and EDC system at Investigator meetings and to internal or external team members, as needed
  • Proactively identifies potential study issues/risks and recommends/ implements solutions
  • Responsible for the accuracy and completeness of the clinical data collected during a clinical trial for all data deliverables
  • Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables
  • Works with partners to increase vendor/partner efficiencies
  • Performs any and all other tasks and activities as requested

Required Qualifications and Background

  • Bachelor’s degree in life sciences, math, computer science or related field required. Master’s degree in life sciences, math, computer science or related field preferred
  • Minimum 10 years’ clinical data management experience, of which 3 must be at a sponsor
  • Demonstrated leadership and project management skills
  • Good working knowledge of ICH, FDA, and GCP regulations and guidelines
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint)
  • Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH)
  • Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
  • Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment
  • Able to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
  • Proven ability to work both independently and/or in a team setting
  • Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment
  • Demonstrated ability to stay abreast of trends and new information in the profession

Additional Preferred Qualifications

  • 5+ years prior oncology/hematology experience highly desirable
  • 5 + years of sponsor experience preferred
  • Recent Phase 3 registration study and submission experience preferred
  • Direct report experience preferred

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position will travel occasionally (15-20%) with some variation based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office setting.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, CMC Pharmaceutics

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s Chemical Manufacturing Controls (CMC) team has an immediate opening for a Senior Manager. The individual will be responsible for aspects of drug product formulations and cGMP manufacturing operations, including oversight of laboratory development work and analytical testing at external research, development, and manufacturing organizations (CDMOs).

Loxo Oncology at Lilly is looking for an independent self-starter with experience designing and manufacturing solid oral dosage forms under cGMP. This individual will be responsible for assisting in preparation of technical reports and drug product sections of CMC regulatory submissions. Experience with the design, development, and manufacturing of liquid and enabled formulations for compounds with low solubility is also highly desired.

Roles and Responsibilities of the Position*

  • Work collaboratively with process chemistry, analytical, DMPK, toxicology, pharmacology, CMC regulatory, and clinical development to develop and deliver appropriate drug products for different phases of animal and human studies
  • Guide CDMOs on pre-formulation characterization and the design of formulations
  • Oversee the development of appropriate analytical testing methods for drug products at various CDMOs
  • Manage the manufacture of drug products for toxicology studies, clinical trials, and commercial supply at CDMOs
  • Author and review technical documents, formulation development reports, and drug product sections for IND, IMPD and global marketing applications

Required Qualifications and Background

  • Ph.D. in pharmaceutics, chemistry, material science, chemical engineering, or related discipline with 4-8 years experience, or Master’s with 6-10 years of experience, or a Bachelor’s degree with 8+ years pharmaceutical industry experience and a minimum of 8 years in a pharmaceutics and formulation development organization
  • Excellent scientific knowledge in pre-formulation, material science, and formulation
  • A track record of successful development of oral solid dosage forms and enabled formulations is highly desired
  • Knowledgeable in good manufacturing practices for the preparation of drug products for clinical studies
  • Experience authoring and reviewing technical documents including, but not limited to; development reports, master batch records, analytical testing methods, and specifications
  • Knowledge of global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug products and able to apply this knowledge to manufacturing strategy to control quality attributes of drug products   
  • Experience in drafting drug product sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong written and oral communication skills
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Detail oriented and well organized
  • Good and thoughtful listener
  • Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position requires occasional travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office with some traveling in the field.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Director, CMC Process Chemistry

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s chemical manufacturing controls (CMC) team has an immediate opening for a Senior Manager or an Associate Director of CMC Process Chemistry. The individual will be responsible for leading and coordinating research and manufacturing operations at external research, development, and manufacturing organizations (CDMOs). Responsibilities will include ensuring that current GMP standards are implemented for the production, testing and control of manufactured drug substance.

Loxo Oncology at Lilly is looking for an independent self-starter with experience designing successful drug substance routes and manufacturing under cGMP.  This individual will be responsible for the preparation of technical reports and drug substance sections of CMC regulatory submissions.

Roles and Responsibilities of the Position*

  • Prepare RFPs and technical packages for the procurement of starting materials and GMP drug substance
  • Author and review technical documents, development reports, and drug substance sections for IND, IMPD and global marketing applications
  • Coordinate shipment of materials for research and GMP activities
  • Assist in the management of activities at drug substance CDMOs. Interact with contract site management and staff (may include being on site).
  • Assist in the management drug substance manufacturing for toxicology studies, clinical trials, and commercial supply at CDMOs, including review and approval of GMP documentation:
  • Change documentation
  • Master and execute drug substance batch records
  • Proactively manage risks/capability and develop mitigation plans. Identify and communicate risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship.
  • Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel
  • Work with QA to prepare drug substance release and stability specifications and provide technical guidance for on-site audits

Required Qualifications and Background

  • Ph.D. in organic chemistry or related discipline with 4+ years experience, Master’s with 7+ years of experience, or a Bachelor’s degree with 10+ years pharmaceutical industry experience and a minimum of 3 years in a process chemistry route development organization
  • Excellent scientific knowledge of process chemistry
  • A proven track record of developing and improving process routes for GLP and GMP manufacturing
  • Prior manufacturing experience, including experience with Contract Manufacturing Organizations
  • Knowledgeable in good manufacturing practices for the preparation of drug substance for clinical studies and commercial supply
  • Experience in drafting drug substance CMC sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong written and oral communication skills
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Detail oriented and well organized
  • Good and thoughtful listener
  • Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This position requires occasional travel.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office with some traveling in the field.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, Finance

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Senior Manager will be responsible for supporting the financial planning, reporting, and analysis of early phase oncology programs.  The position will partner with financial stakeholders including management, Asset teams, Clinical Operations and R&D. This position will act as a key member of the finance and accounting team, providing support for strategic, and financial decisions.

Roles and Responsibilities of the Position*

  • Responsible for providing hands-on FP&A support across the organization with the focus on the development of early phase oncology programs.
  • Attend all asset and development team meetings.
  • Assist in coordinating the budget and projection processes across the Asset Teams ensuring deliverables are timely reviewed and submitted for approval, if required.
  • Provide insightful and timely business performance updates to the business and key internal stakeholders by Identifying business trends, analyzing actual results, and meaningfully synthesizing and presenting financial results against plan.
  • Develop, plan, and coordinate budgets/forecasts and provide regular robust actual reporting and variance analyses to assigned Asset teams, cost center managers and key business stakeholders to enable decision making and alignment to company goals.
  • Track key metrics to enable proactive monitoring and early warning of financial performance versus contract agreements and plan.
  • Identify risks & opportunities to the business while aggressively challenging barriers.
  • Assist in managing the overall financial planning and reporting calendar.
  • Assist in preparing various presentations for senior management.
  • Prepare quarterly and on-demand financial presentations which accurately and insightfully present the results of business operations and/or future projections.
  • Assist in accounting processes related to internal/external forecast, monthly accruals & financial close.
  • Assess, identify and recommend process development improvements relating to budgeting, forecasting, period close process, and financial reporting.
  • Partner with Procurement and key business groups to monitor key/large vendors obligations.
  • Partner with Human Resources to stay informed of resource planning activities.
  • Work closely with Accounting and key business groups to assist in tracking and forecasting CRO and related vendor activities as part of period close process.
  • Assist with Capital planning.
  • Assist with completing Corporate Finance’s annual financial Strat Plan.
  • Assist with the preparation and presentation of quarterly and/or periodic senior management team financial review packages.
  • Participate in other ad hoc projects, roles, and workload sharing within Finance and Accounting as appropriate.
  • Assist in promoting a culture of excellence and instilling best practices across Finance and Accounting.
  • Building and maintaining collaborative relationships across the company.
  • Maintain sound internal controls environment and ensure compliance with local laws and Company’s policies.
  • Other duties as assigned.

Required Qualifications and Background

  • Bachelor’s degree (or equivalent experience) with a minimum of 8-10 years of experience in a similar role preferably in the biotechnology or pharmaceutical industry; MBA preferred.
  • Highly proficient in Excel (including the ability to perform pivot tables and complex functions and formulas, such as VLOOKUP) and PowerPoint
  • Demonstrated experience utilizing enterprise-grade, commercial ERP systems and reporting software; SAP experience a plus.
  • Working knowledge of Generally Accepted Accounting Principles (US GAAP) is a plus.
  • Attentive to accuracy and detail with the ability to analyze and synthesize large amounts of data for reporting and problem-solving.
  • Excellent organizational skills; and an ability to prioritize effectively to deliver results within reasonably established timelines; result-oriented with a strong belief in personal integrity and accountability.
  • Ability to work independently and as part of a team; self-motivated and directed; possesses a sense of urgency and will follow through to completion.
  • Ability to work effectively in a fast pace environment often with aggressive deadlines and quick turnaround with minimal direction and capable of adjusting workload based upon changing priorities.
  • Ability to build relationships; strong interpersonal skills including verbal and written communication are essential in this collaborative work environment; customer-service orientation.

Physical Demands / Travel

The physical demands of this job are consistent with light office work. From time to time domestic travel to various company sites and labs may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, Medicinal Chemistry

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s Drug Discovery team has an immediate opening for an experienced medicinal chemist. The Loxo Oncology at Lilly team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for accomplished medicinal chemists with a proven track records of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to solve medicinal chemistry challenges and will excel at working closely with scientists across disciplines. The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.

Roles and Responsibilities of the Position*

  • Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
  • Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
  • Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
  • Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
  • Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
  • Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
  • Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.

Required Qualifications and Background

  • B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
  • 5+ years of experience in small molecule drug discovery in a biotechnology or pharmaceutical setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
  • Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
  • Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.

Physical Demands / Travel

The physical demands of this position are consistent with working in a laboratory/ bench environment. Some light lifting and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a laboratory/ bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Associate Director, Medicinal Chemistry

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology at Lilly’s Drug Discovery team in Boulder, Colorado has an immediate opening for an experienced medicinal chemist. The Loxo Oncology at Lilly team’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we have built a multi-disciplinary team of dedicated drug discovery scientists who are passionate about driving the science forward to create highly selective drugs for known oncogenic drivers. We are currently looking for accomplished medicinal chemists with a proven track records of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to solve medicinal chemistry challenges and will excel at working closely with scientists across disciplines. The position requires excellent people skills, a positive can-do attitude, and the ability to thrive in a highly interactive, fast-paced, team environment.

Roles and Responsibilities of the Position*

  • Drive the team forward with new medicinal chemistry analogs that consistently move the project toward the next breakthrough drug candidate.
  • Optimize lead series for potency, selectivity, physiochemical properties, in vitro ADME, and PK by coupling multivariant SAR analysis with hypothesis-driven medicinal chemistry design principles. Use sound scientific methods to propose hypotheses and determine next steps even with complex or ambiguous data.
  • Work closely with structural biology and computational chemistry colleagues to design novel compounds and hypotheses that address key drug optimization goals.
  • Reduce ideas to practice in the lab quickly by effectively employing a broad range of modern organic chemistry transformations, synthetic methods, purification and characterization techniques.
  • Synergize with the broader team by communicating results, sharing insights, making plans, and setting goals in an open, honest way.
  • Provide medicinal chemistry insight for new target and lead identification and evaluation initiatives in the oncology space.
  • Proactively investigate new or different technologies to improve the effectiveness of the drug discovery process.

Required Qualifications and Background

  • B.S., M.S. or Ph.D. in Chemistry with a focus on synthetic organic chemistry.
  • 5+ years of experience in small molecule drug discovery in a biotechnology or pharmaceutical setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Extensive experience in lead compound optimization for potency, selectivity, ADME and PK.  
  • Experienced in the use of synthetic chemistry instrumentation: HPLC, LC-MS, NMR, and purification systems.
  • Expert in using common medicinal chemistry software: electronic notebook, ChemDraw, Excel; data visualization; structure viewing; literature, chemical and database searching.
  • Committed to staying current with the latest scientific breakthroughs in the medicinal chemistry field through continued reading of the literature and attendance of scientific conferences. 
  • An excellent team player with ability to communicate synergistically with a multidisciplinary team and be accountable for the medicinal chemistry progress of the project. Highly organized with excellent analytical, documentation, time management, and multi-tasking skills.

Physical Demands / Travel

The physical demands of this position are consistent with working in a laboratory/ bench environment. Some light lifting and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a laboratory/ bench environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Director, Statistical Programming

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Statistical Programmer is responsible for providing Statistical Programming activities across in support of one or more clinical stage programs. Responsibilities will include: support of workflow in generation of study-specific and ad-hoc clinical data listings, summary tables and figures; performing data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.

Roles and Responsibilities of the Position*

  • Perform data analysis using primarily the SAS programming language for the summary and interpretation of clinical trial data.
  • Create and review CDISC SDTM and ADaM files, SAS export files and Define.xml use for Electronic Submission from the data received in non-standard form from various sources.
  • Perform data analysis, statistical analysis, generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
  • Develop SAS coding and table templates for preparing, processing and analyzing clinical data.
  • Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
  • Review Data Management Plan, Data Validation Plan and edit check specifications.
  • Interact cross functionally with Statisticians and other members of the clinical team to perform ad hoc analysis and generate outputs according to the requirements.
  • Implement and contribute to statistical analysis plans; provide additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection. 
  • Recognize inconsistencies and initiate resolution of data problems
  • Act independently to determine methods and procedures on new assignments.

Required Qualifications and Background

  • Bachelor/Master’s degree in Statistics, Life Sciences, Computer Sciences, or Mathematics with a minimum 3-5 years Pharmaceutical/Biotech programming experience.
  • Experience in the analysis of complex oncology and/or hematology clinical trial data.
  • Solid knowledge of SAS Programming language.
  • Experience with integrated summaries (ISE/ISS) and Clinical Study Reports.
  • Proven ability to work both independently and in a team setting.
  • Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).
  • Excellent verbal/written and interpersonal skills.
  • Ability to communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
  • Ability to work effectively in a fast-paced environment with a positive “can-do” proactive attitude.

Physical Demands / Travel

This position will travel occasionally based upon the demands of the business imperatives.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is based in a typical office setting.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Principal Scientist, Structural Biology

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to be part of Loxo’s discovery teams focused on creating novel, highly specific and selective drugs for genetically identified targets. The Senior Structural Biologist will offer structural and mechanistic insights to a multi-disciplinary discovery team by providing high-resolution protein-ligand crystal structures.

Roles and Responsibilities of the Position*

  • Generate protein-small molecule complex x-ray crystal structures with hands-on lab involvement throughout the entire gene to structure process including protein expression, purification, crystallization, and structure determination.
  • Coordinate protein construct design, expression, and purification with the project team to support biochemical and biophysical assays.
  • Rapidly communicate scientific results and insights to the team.
  • Identify, evaluate, and manage vendors for outsourced services and studies.
  • Collaborate with colleagues throughout the company to ensure structural work meets the program needs and results are appropriately interpreted.
  • Prepare reports for internal and external purposes including regulatory submissions.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies. 
  • Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.
  • Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way.
  • In the future, this position’s responsibilities may include supervision of scientists and associates.

Required Qualifications and Background

  • PhD in Biochemistry, Chemistry, or related field
  • Ideal candidate will have with 5+ years hands-on gene to structure protein-small molecule crystallography experience in a biotech/pharma setting.
  • Highly skilled in crystallization of protein-small molecule complexes and high-resolution x-ray structure determination
  • Extensive experience in protein construct design, expression, purification, and characterization
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Committed to staying current with the latest scientific breakthroughs in structure-based drug design and structural biology.
  • Expertise in other methods of biophysical and structural biology, such as Cryo-EM, is a plus.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and the lab.  

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Executive Director, Quality Assurance

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

Loxo Oncology is seeking a highly motivated Specialist, Quality Systems who is an excellent influencer and enjoys a fast paced, dynamic work environment. The ideal candidate has demonstrated knowledge of GXP pharmaceutical Quality Systems and possesses sound judgment, capable of obtaining tangible results in a short period of time. This individual must assist with managing Loxo Quality Systems and will work collaboratively with both internal and external colleagues to influence mindset and provide proactive compliance. 

Roles and Responsibilities of the Position*

  • Manages the Loxo training program and document management functions.
  • Must be a hands-on leader who can provide strategy for the functions as well execute processes.  Must be able to work with a sense of urgency.
  • Duties include:
    • Processing SOPs through document lifecycle (e.g. SOP creation, QC review, circulate for review, approval, periodic review, etc.).
    • Reviewing of SOPs for compliance with GxPs and regulatory requirements
    • Driving the Loxo training program which includes assisting in curricula development through approval and managing employee training files.
    • Assigning training and ensuring training is up to date.
    • Collaborates with internal Loxo departments and with Loxo’s parent company to identify training needs.
    • Collaborates with IT and QA Program Manager to problem solve system related issues
  • Additional responsibilities may include supporting inspection readiness, metrics reporting for Quality system elements, etc.
  • Works with internal departments to ensure continuous improvement of processes / procedures and quality of work product.

Required Qualifications and Background

  • Bachelor's Degree is required in science, health or related field 5-7+ years’ experience in the Biotech/Pharmaceutical industry (21 CFR 210 and 211).
  • Working knowledge of IT Quality System solutions and associated compliance requirements, which includes but is not limited to; system implementation, execution and change management (Veeva systems a plus)
  • Strong working knowledge of global regulations and guidelines for early phase pharmaceutical development (e.g. FDA/EU and ICH)
  • Broad and direct experience supporting regulatory authority inspections
  • Flexible in the face of shifting needs and/or priorities.
  • Able to interface well with all levels of personnel, including peers and other department heads such as: IT, Clinical Operations, Data Management, CMC, Clinical Science, Regulatory, Biostatistics, Drug Safety, Translational Research, Supply Chain and Project / Program Management.
  • Capacity to produce high quality results across multiple projects and demands, through effective prioritization, while working under short deadlines associated with a fast-paced dynamic scientific environment.
  • Excellent communications skills, both written and verbal.
  • Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
  • Strategic thinker, open-minded and flexible to adopting new ideas.
  • Motivated, committed and self-managed.
  • Willingness to work in a dynamic and changing corporate environment
  • Requires a flexible work schedule to accommodate program priorities and international activities as needed.
  • Exceptional attention to detail.

Physical Demands / Travel

There are no specific physical demands for this position. 

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

Ability to travel 15%. No specific work demands.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

Senior Principal Scientist, Structural Biology

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

This position offers the opportunity to be part of Loxo’s discovery teams focused on creating novel, highly specific and selective drugs for genetically identified targets. The Structural Biologist will offer structural and mechanistic insights to a multi-disciplinary discovery team by delivering high quality protein, protein: small molecule complex crystals, and protein-ligand crystal structures.

Roles and Responsibilities of the Position*

  • Generate protein-small molecule complex x-ray crystal structures with hands-on lab involvement throughout the gene to structure process including protein expression, purification, crystallization, and structure determination.
  • Coordinate protein construct design, expression, and purification with the project team to support biochemical and biophysical assays.
  • Rapidly communicate scientific results and insights to the team.
  • Collaborate with colleagues throughout the company to ensure structural work meets the program needs and results are appropriately interpreted.
  • Prepare reports for internal and external purposes including regulatory submissions.
  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies. 
  • Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design.
  • Proactively investigate new or different technologies, methods, and service providers to ensure our work is being done in a scientifically sound, efficient, and reasonable way
  • In the future, this position’s responsibilities may include supervision of scientists and associates.

Required Qualifications and Background

  • BA/BS, MS in Biochemistry, Chemistry, or related field
  • Ideal candidate will have with 2-5+ years hands-on gene to structure protein-small molecule crystallography experience in a biotech/pharma setting.
  • Highly skilled in crystallization of protein-small molecule complexes.
  • Extensive experience in protein construct design, expression, purification, and characterization.
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Committed to staying current with the latest scientific breakthroughs in structure-based drug design and structural biology.
  • Expertise in other methods of biophysical and structural biology, such as Cryo-EM, is a plus.

Physical Demands / Travel

The physical demands of this job are consistent with light office duties.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and the lab. 

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Reports To:

VP, Small Molecule Biology

Position Summary

Loxo Oncology at Lilly conducts discovery research, clinical development and regulatory affairs for oncology, with the goal of creating a pipeline of therapies that have the potential to make a meaningful difference for patients. Loxo Oncology at Lilly was created in December 2019, combining the Lilly Research Laboratories oncology organization and Loxo Oncology, which was acquired by Lilly in early 2019. The unit has team members in Boulder, CO, Indianapolis, IN, New York City, South San Francisco, Stamford, CT, and Madrid, Spain.

The Translational Biology Group Leader will be responsible for leading a research team focused on in-depth studies to provide clinically-focused research to guide discovery projects, biomarker strategies, and early clinical development. The translational biology team will work on multiple drug discovery projects and early clinical programs across solid tumors and hematological malignancies providing mechanism-based studies to characterize prototype, literature, and clinical compounds in clinically relevant in vitro and in vivo assays. In addition, the translational biology team will develop and characterize drug resistance mechanisms in in vitro and in vivo models, identify and test drug combinations based on molecular mechanism, and analyze clinical trial patient molecular characterization results to inform discovery, clinical, and diagnostic programs. The translational biology team will work closely with other project team members across disciplines including cell biology, in vivo pharmacology, medicinal chemistry, biochemistry, bioinformatics, and clinical leads.

Roles and Responsibilities of the Position*

  • Participate and lead project-based and technical team meetings to identify and solve problems, guide work towards project goals, communicate on-going work and progress, and plan forward thinking strategies.
  • Actively participate in their team’s research activities (i.e. experimental work, experimental design, advanced analysis, etc.)
  • Effectively communicate biomarker strategies and assays to clinical teams, while also ensuring that insights from the clinical studies   inform discovery projects.
  • Supervise and mentor cell biologists and biochemists engaged in Loxo Oncology at Lilly translational research projects to think deeply and work creatively while delivering excellent scientific results and insights to the project teams and their colleagues.
  • Develop and continually advance one’s knowledge base on the molecular pathways being targeted by our discovery, clinical and research programs.
  • Proactively investigate new or different technologies and methods to advance our discovery projects

Required Qualifications and Background

  • PhD in Molecular/Cellular Biology, Biochemistry, or related field with 8+ years hands-on cell biology experience in a biotech/pharma setting OR BS/MS in Molecular/Cellular Biology, Biochemistry, or related field with 12+ years hands-on cell biology experience in a biotech/pharma setting
  • 2+ years of experience working on hematological malignancies

Additional Preferred Qualifications

  • Demonstrated experience supervising 2 or more scientists.
  • Expertise in designing and commissioning in vivo efficacy studies using cancer cell line and patient-derived xenograft models, to test oncology compounds
  • Strong background in cancer cellular signaling pathway experimentation and experimental curve-fitting and statistics
  • Thorough understanding of engineering knock-in and knockdown cell lines with CRISPR and/or other technologies
  • Experience with early clinical trial studies and the development and implementation of pharmacodynamic and patient selection biomarker assays
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Committed to staying current with the latest scientific breakthroughs in the targeted oncology field from target identification through human clinical trials
  • Good and thoughtful listener who values collaboration
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

The physical demands of this job are consistent with light office duties and some laboratory work. Some light lifting, and maneuvering may be required.

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

This position’s work environment is in an office and laboratory environment.

The work environment characteristics described here are representative of those encountered by an employee while performing the essential functions of this job.

*To perform this job successfully, an individual must be able to perform each role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.


Position

Outstanding Team Member

Location

Stamford, CT, South San Francisco, CA, or Boulder, CO (or another location to be determined)

Position Summary

Patients are at the heart of everything we do at Loxo Oncology, and we continue to be motivated by that goal. We pursue this goal with a tenacity, focus and commitment to excellence that defines who we are and how we work.

We seek dedicated, passionate, hardworking intelligent, thoughtful and authentic individuals who thrive within a collaborative and fast-paced environment and will bring their experiences, unique perspectives and problem-solving skills to the team. In return, we cultivate an environment that rewards and recognizes hard work and provides opportunities for learning and growth as part of a team making a meaningful difference in the field of medicine and for individual patients.

If you share our passion, please let us know how you could contribute to our team. We don't want to pass up an opportunity for the right candidate to join us just because you found us before we found you.

Connect With Us

Submit your resume and your "Who", "What" and "Why" (see below) to careers@loxooncology.com.

Your "Who", "What" and "Why":

  • Who are you?
  • What will you bring to Loxo?
  • Why do we need you on the team?

Loxo Oncology, Inc. is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.