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:

TBD

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 are seeking an experienced Administrative Assistant/Receptionist for our South San Francisco office. The right candidate will be a positive, proactive individual who enjoys working with and supporting our internal team as well as guests and external vendors visiting our South San Francisco office. We seek a detail-oriented professional excited to contribute to our mission, learn and grow within the role, and act as the face and voice of Loxo at our South San Francisco location.

Roles and Responsibilities of the Position*

This position interacts with internal contacts at all levels of the organization as well as a diverse group of important external callers and visitors. Independent judgment is required to plan, prioritize and organize a diversified workload and recommend improvements in office practices or procedures. Responsibilities include:

  • Provide administrative support including typing, filing, calendar management, booking travel, reconciling expenses, meeting coordination and other administrative tasks.
  • Answer non-routine correspondence and assemble highly confidential and sensitive information.
  • Assist with other special projects as needed, including assisting with offsite meetings, events, large print/copy jobs, projects, coordinating external vendors, etc.
  • Coordinate and facilitate the use of all conference rooms.
  • Greet visitors, and work closely with the team to ensure interviews and meetings remain on schedule.
  • Assist with ordering, set-up/cleanup of office lunches (and dinners when necessary).
  • Restock kitchen supplies daily (or more frequently depending on need).
  • Clean and restock the coffee machine weekly (or more frequently depending on need).
  • Send and receive packages via USPS, UPS and FedEx.
  • Collect and distribute the mail daily (or more frequently depending on need).
  • Maintain copy rooms and printers/copiers in coordination with the IT team.

Required Qualifications and Background

  • Minimum of 3+ years in a comparable Administrative/Office Coordinator/ Assistant/Receptionist role.
  • Positive, eager and helpful attitude.
  • Professional demeanor and excellent written and verbal communication skills.
  • Able to work within a fast-paced environment, adept at juggling multiple tasks and priorities and prioritizing independently.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Effective collaborator with a variety of stakeholders, thoughtful listener and team player.
  • Able to maintain a calm, patient and “can-do” approach.
  • Conscientious, detail-oriented, well-organized and takes initiative to anticipate and address needs.
  • Able to bring a proactive and creative approach to problem solving.
  • Proficient in Microsoft Office suite and applications.
  • Please note: this role requires an on-site presence from 8:30am-5pm, Monday to Friday (and additional hours if/as needed).

Physical Demands / Travel

The physical demands of this job are consistent with light office duties; candidate should have the capability to lift up to 10lbs.

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 roles and responsibilities 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.


Reports To:

Executive Director, Quality Assurance

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.

The Associate Director, Quality Assurance is responsible for all aspects of Quality Assurance and GCP compliance. The Associate Director, Quality Assurance will establish and execute quality plans, policies and quality system elements related to GCP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to, an SOP system, CAPAs, site and vendor audits and work closely with the Clinical Operations team. The Associate Director, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GCP international regulatory environment and provide GCP guidance in quality related areas. This position will report to the Executive Director, Quality Assurance.

Roles and Responsibilities of the Position*

  • Liaise across departments to proactively identify opportunities to streamline and strengthen GCP process.
  • Serves as GCP SME when SOPs are written or revised.
  • Manages Quality Events and Actions (Process Deviations, CAPA) within a regulated Quality Management System.
  • Represents GCP expertise on cross-functional teams for GCP related process improvements resulting from new/revised regulations or guidance.
  • Collaborates cross functionally and represents Quality on study teams.
  • Conducts GCP audits of clinical sites and vendors.
  • Utilizes Loxo Quality Systems to manage Quality elements.
  • Supports inspection readiness activities and external Health Authority inspections.

Required Qualifications and Background

  • Minimum BS, master’s degree or PhD with focus in Chemistry, Life Sciences, Engineering or similar technical field.
  • 10+ years current work experience in pharmaceutical industry Quality Assurance required.
  • 10 or more years of experience working in either a clinical compliance or Quality group.
  • Demonstrated Quality Management System experience (GCP specific QMS experience preferred).
  • Demonstrated Issue Management and CAPA experience in a clinical environment.
  • Demonstrated skills in taking initiative and working independently.
  • Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.
  • 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.
  • 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 in addition to attention to detail and accuracy of work.
  • 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.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Critical thinker and solution oriented.
  • Enthusiastic, self-motivated and self-starter.
  • 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 roles and responsibilities 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.


Reports To:

Executive Director, QA

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.

The Associate Director, Quality Assurance is responsible for all aspects of Quality Assurance and GxP compliance. The Associate Director, Quality Assurance will establish and execute quality plans, policies and quality system elements related to GxP activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system, batch record review/release, training program, CAPA/deviations, and perform internal and external audits at clinical sites and clinical and commercial suppliers. The Associate Director, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment and provide GxP guidance in Quality related areas. This position will report to the Executive Director, Quality Assurance.

Roles and Responsibilities of the Position*

  • Provide expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to assure GxP compliance.
  • Responsible for release and disposition of drug substance and drug product for clinical and commercial use.
  • Support the GxP vendor qualification and oversight process and be an SME in both areas of GCP and GMP.
  • Investigate product complaint system and interact with the contracted complaint vendor.
  • Conduct GxP compliance auditing program to fulfill regulatory requirements.
  • Support GMP/GCP risk profile process & mitigation through the Quality Planning Process.
  • Support product recall/market withdrawal process.
  • Support the management of pharmaceutical quality systems & continuous improvement.
  • Interact and develop relationships with vendors’ quality leaders through audits, project teams, and established one-on-one relationships.
  • Review and approve product specifications, GxP related deviations and CAPAs.
  • Write GxP Quality SOPs in support of Loxo Quality Systems.
  • Ensure compliance with corporate policies and procedures as well as US healthcare laws and regulations.
  • Support regulatory inspections of Sponsor, GCP sites and GxP vendors.
  • Provide reviews of regulatory dossiers (IND, IMPD, NDA, MAA, etc.).

Required Qualifications and Background

  • Minimum BS, Master’s degree or PhD with focus in Chemistry, Life Sciences, Engineering or similar technical field.
  • 10+ years current work experience in pharmaceutical industry Quality Assurance required.
  • Expert knowledge of manufacturing, clinical, and analytical services employed in the pharma industry.
  • Solid and demonstrable knowledge of international GMP and GCP regulations and guidelines, industry practices, and experience implementing quality systems in a regulated environment; knowledge of GLP regulations.
  • Leadership in GxP vendor management and oversight.
  • Proven background in internal, vendor, and regulatory auditing and audit management.
  • Knowledge of risk management, mitigation, and controls.
  • Experience with complaint management.
  • Strong organization and time management skills.
  • Attention to detail with an ability to perform critical review of various types of documents.
  • Outstanding written and verbal skills.
  • Ability to travel to vendor sites (up to 25%).
  • 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.

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 with up to 25% travel required.

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 roles and responsibilities 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.


Reports To:

Senior Director, Translational Medicine

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.

The Associate Director/Director Biomarker Operations will contribute to biomarker research and the development of diagnostic technologies for the Loxo Oncology drug pipeline by overseeing all patient sample collection, processing and analysis operations for Loxo’s clinical trials. The successful candidate will achieve this objective with the assistance of a biospecimen manager and in close collaboration with his/her Loxo clinical development colleagues, by directing activities at a network of external, contract labs.

Roles and Responsibilities of the Position*

The role is primarily focused on overseeing all clinical trial activities related to patient sample collection and processing, including (1) authoring select sections of clinical trial protocols, lab manuals and informed consent forms, (2) piloting and setting up central labs that process, store and analyze patient samples, and (3) validation of external labs providing reports utilized for enrollment purposes. The Operations lead also will oversee the existing biospecimen repository function, which includes sample inventory tracking, sample logistics and sample database maintenance. As time permits and depending on the individual, he/she may also contribute to the design and execution of clinical correlative studies and the team’s other research and diagnostic development projects.

Required Qualifications and Background

  • Masters or Ph.D. in a biological discipline.
  • At least 5 years of pharma and/or diagnostics industry experience, with a focus on translational medicine and/or operations.
  • Self-organized, 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.

The ideal candidate will have experience with several of the following:

  • Management of biorepository operations and databases.
  • Contracting, piloting and validating contract labs.
  • Management of teams at contract labs.
  • Writing of clinical trial protocols, lab manuals and consent forms.
  • Procedures for collecting and processing of clinical specimens.
  • Organization and coordination of multiple projects in parallel.
  • NGS and other high throughput genotyping technologies.
  • Extraction of DNA, RNA & proteins, particularly from FFPE samples.
  • RT-PCR and NGS assays of RNA abundance, CNVs and/or SNVs.
  • Extensive experience with Microsoft Office, particularly Excel
  • Well-developed program and project management execution, communication, and presentation skills.

Physical Demands / Travel

It is expected that the successful candidate will spend 15% of his/her time traveling on behalf of the company.

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 roles and responsibilities 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.


Reports To:

Executive Director, Regulatory Affairs

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.

The Associate Director/Director, Regulatory Affairs will contribute to the formulation of regulatory strategy, serve as the regulatory lead on relevant project teams, and act as the regulatory contact for US/Global health authorities as required. This individual will oversee the planning and execution of major submissions and responses to regulatory authorities related to IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing book for FDA meetings, as well as responses to requests.

Roles and Responsibilities of the Position*

  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs
  • Provide regulatory leadership and guidance to project teams
  • Develop response strategies and submissions to regulators
  • Develop briefing packages for meetings with FDA and other global health authorities
  • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through commercial)
  • Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
  • Manage or delegate the management of the 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
  • Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
  • Identify and assess regulatory risks for assigned projects or programs
  • Prepare and deliver effective presentations for external and internal audiences
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate
  • Participate and contribute in Health Authority meetings as required

Required Qualifications and Background

  • MS degree in life/health/technical sciences preferred
  • Minimum 8+ years’ regulatory experience within the biotech or pharmaceutical industry within the drug development and approval process in INDs/NDAs
  • Proven experience navigating successful submissions in the Oncology space is required; Preferences include recent successful NDA experience
  • Knowledge and understanding of global regulatory requirements
  • Ability to work both independently with minimal direction and within project teams, committees, corporate partners, etc. to attain group goals
  • Demonstrate excellent communication skills
  • Ability to represent the group in project teams
  • Demonstrate strong organizational skills, including the ability to prioritize tasks
  • Experience in interfacing with relevant regulatory authorities
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Experience in interpretation and application of regulations, guidelines, policy statements, etc.

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 roles and responsibilities 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.


Reports To:

Senior Manager, Clinical Data Management

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.

The Contract Clinical Data Manager is responsible for overseeing data management tasks from study start-up through database lock for clinical trials. This individual collaborates with the Clinical Trial Managers (CTMs), Biostatistics team, and data management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. The Clinical 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 in study team meetings
  • 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
  • Oversight of data management CRO/service providers on assigned studies
  • Monitors the progress of all data management activities on assigned studies to ensure project timelines are met
  • 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, able to work independently towards the assigned goal
  • Provide DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables

Required Qualifications and Background

  • Bachelor degree in Life Sciences, Computer Sciences, Mathematics, health related field or equivalent experience
  • 6+ years of CDM experience in the pharmaceutical or biotechnology industry
  • CRO management experience a plus
  • Prior oncology/hematology experience highly desirable
  • Requires solid knowledge of clinical data management principles, clinical trials process and regulatory requirements
  • 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
  • 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, CDASH)
  • Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
  • Proven ability to work both independently or in a team setting

Physical Demands / Travel

This position will travel occasionally; the average travel for this position is 10-15% 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

The position’s work environment is based in a typical office setting with occasional travel required.

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 roles and responsibilities 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.


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.

The Clinical Pharmacologist acts as the primary clinical pharmacology lead providing clinical pharmacology expertise to multidisciplinary study and development teams. Will be the key expert on all clinical pharmacology matters relating to assigned projects. The individual will be responsible for the designing, planning and execution of clinical pharmacology strategies & studies in support of development of small molecule drugs in the oncology therapeutic area.

Roles and Responsibilities of the Position*

  • Drive the clinical pharmacology strategy and planning for clinical programs.
  • Responsible for the interpretation of all bioanalytical, pharmacokinetic, pharmacodynamic and population pharmacokinetic data generated to support individual studies or on a programmatic level and ensure results are communicated appropriately and in a timely manner to project teams
  • Provide input into (including authoring and review of) clinical pharmacology protocols, study reports, investigator brochures, background packages for regulatory interactions, regulatory submissions, and pharmacokinetic, population pharmacokinetic and pharmacokinetic/pharmacodynamic statistical analysis plans.
  • Serve as the point of contact for any out-sourced bioanalytical, pharmacokinetic, population pharmacokinetic, pharmacokinetic/pharmacodynamic analyses or other modeling efforts and be responsible for developing a scope of work, facilitating the execution of master service agreements and contracts, and analysis plans to ensure resources are being utilized efficiently and effectively to support study or project team objectives.
  • Manage interactions with out-sourced bioanalytical and pharmacokinetic analysis and modeling efforts to maintain good business relationships with external vendors and consultants.
  • Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development.

Required Qualifications and Background

  • PhD, PharmD, MD or equivalent in pharmacokinetics, pharmacology or pharmaceutical science is required; industry experience in conducting clinical stage drug development is strongly preferred.
  • Minimum 6 years of multi-disciplinary experience in the biotech/pharmaceutical industry knowledge of the overall small molecule drug development process.
  • Minimum 2 years direct clinical pharmacology experience in healthy volunteer and oncology patient studies including working scientific, regulatory, clinical and operational knowledge base
  • Training and experience in pharmacokinetic analysis and/or modeling and simulation (e.g., WinNonlin, NONMEM).
  • Excellent contingency planning and time management skills and demonstrated ability to manage a number of projects simultaneously.
  • At a minimum, strong candidates will demonstrate the following:
    • Demonstrated understanding and experience in clinical pharmacology.
    • Excellent interpersonal skills with the ability to develop important relationships with customers and key stakeholders.
    • Effective communication and presentation skills with the ability to communicate complex information effectively.
    • Strong influencing and negotiation skills.
    • Proven track record of good decision making and exercising sound judgment.
    • Embraces working in a culture where receiving and providing feedback is valued.
    • Results and detail-oriented.
    • Self-motivated.

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 roles and responsibilities 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.


Department:

Clinical Operations

Reports To:

Associate Director or Director, Clinical Operations

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.

The Clinical Research Associate, in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs. Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.

Roles and Responsibilities of the Position*

Project Management:

  • Provide operational input on development, management and maintenance of study deliverables [i.e. timelines, study plans, documents, etc.] through collaboration with internal and external stakeholders.
  • Use performance metrics and quality indicators to assist the Clinical Trial Manager in driving study execution.
  • Participate in monitoring visit report review process to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
  • Support Health Authority inspections and CQA audits as required.
  • Ensure full compliance (completeness and accuracy) of the required data in study management tools including clinical trial management systems, patient enrollment forecasting, etc.
  • Provide proactive identification of potential risks and develop and implement actions to avoid or mitigate.
  • Develop and maintain collaborative relationships with internal and external partners/stakeholders.

Study Planning and Conduct:

  • Collaborate with vendors and Loxo CTM’s regarding study specific issues and follow through to resolution.
  • Assist in the creation and review of study documents, including but not limited to the Protocol, Protocol Synopsis, Informed Consent Form (ICF) and other patient facing materials and assist in updating these study documents as needed.
  • Participate in vendor specification development and management/oversight.
  • Assist with management of TMF set-up, ongoing quality review, and final reconciliation.
  • Assist with shipment and reconciliation of Investigational Product (IP) at study and site level as needed.
  • Actively contribute to study meetings including presenting as a subject matter expert, generating, finalizing and distributing study team agendas and recording meeting minutes as needed.
  • Contribute to development/coordination of study training and study training materials for study team, investigational sites, and vendors.
  • Contribute to oversight of the required country regulatory (e.g. CTA, MoH) and country/site IRB/IEC submissions/approvals/notifications.
  • Assist with the collection of various study documents such as country/site insurance, CSR appendices, etc.
  • Assist with investigator meeting coordination and planning.

Required Qualifications and Background

  • Degree in a relevant discipline with experience in the Clinical Trial environment required.
  • Knowledge of ICH/GCP and regulatory guidelines/directives.
  • Demonstrates analytical approach and anticipation of problems.
  • Identifies gaps and provides constructive feedback and solutions.
  • Ability to multi-task effectively and prioritize assignments from multiple sources.
  • Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments.
  • Knowledge of study tools including electronic system skills such as CTMS / EDC/ IRT/eTMF.
  • Knowledge of drug development process.
  • Proactively shares information, ideas, input, and/or expertise with team members.
  • Demonstrates concern for high quality outcomes.
  • Responds flexibly to changing business demands and opportunities, proactively looks for ways to contribute.
  • Basic understanding of project management desired.
  • Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint.
  • Strong oral and written skills with proficiency in English.
  • Excellent organizational skills

Physical Demands / Travel

This position may require up to 25% travel. Some of the travel may be international.

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 the field and 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 roles and responsibilities 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.


Reports To:

Associate Director, Clinical Scientist

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.

This position offers the opportunity to participate in the entire spectrum of the drug development process. Loxo designs drugs “from the ground up” by selecting a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. This role is integral in moving 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. The Clinical Scientist will participate directly in improving the lives of people fighting their cancers.

Roles and Responsibilities of the Position*

In tandem with the Medical Director this role designs, implements and executes Phase 1, 2 and 3 clinical trials for ultimate culmination in clinical study reports and NDA/MAA submissions. Excellent communication skills are important, as the position interacts with a variety of collaborators, including colleagues, outside consultants, clinical research sites, and key opinion leaders.

Loxo is a small company highly focused on clinical and regulatory execution. As a key member of the team, the Clinical Scientist 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 individual 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.
  • Creates and fosters 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, implementation, operations/study management and interpretation of clinical trials.
  • Lead the writing of protocols, informed consent forms, clinical study reports and regulatory-related documents.
  • Work closely and liaise regularly with clinical sites and investigators to ensure implementation of clinical studies.
  • 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 be accountable for study start up activities, site initiation visits, interpretation of interim data analyses, clinical data review, and preparation of dose escalation meetings.
  • Ensure trials are conducted effectively, reach target enrollment, and are conducted within budget and time-constraints, in partnership with CROs and Loxo regional and in-country groups, to deliver submission-quality data.
  • Demonstrate efficiencies in the areas of budget management, contracting and resourcing.
  • Demonstrate substantial and relevant knowledge of scientific and medical literature in oncology and its application to strategic design and operational achievements.
  • Work with external experts to develop abstracts, manuscripts, study/program design and presentations.
  • 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 act 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 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.
  • Travel up to 20%, may include international travel

In summary, qualities sought include: intrinsic motivation, excellent communication and organizational skills; a passion for biomedicine and for patients; broad prior experience in drug development; and a comfort and desire to learn new skills.

Physical Demands / Travel

This position requires approximately 20% travel, which will fluctuate as business imperatives change.

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 the field, occasionally in a lab and within 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 roles and responsibilities 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.


Reports To:

Associate Director, Clinical Supply Management

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.

The Specialist, Clinical Supply Management will support Clinical Supply Management by contributing to various work streams with internal and external team members for the on-time delivery of clinical supplies across the Loxo portfolio.

Roles and Responsibilities of the Position*

  • Update and maintain study supply plans including drug supply forecasts for manufacturing, packaging, and labeling operations.
  • Provide oversight of contract packaging and distribution vendors including, but not limited to, document review of packaging specifications, master and executed batch records, distribution instructions and order processing and delivery.
  • Provide on-going monitoring of inventory and expiration dates for assigned program/study. Ensure alignment with supply forecast and study/program requirements.
  • Manage global accountability tracking including destruction for assigned programs.
  • Support clinical label development process including creation of master label text, translations, and label proofs.
  • Review and provide input to documents including, but not limited to: pharmacy manuals, IMPDs, request for proposals, and IRT specifications.
  • Participate on project teams and sub-teams as needed and assigned
  • Track progress versus timelines and goals.
  • Ensure documents and records are kept in compliance with regulations and SOPs including the Trial Master File (TMF).

Required Qualifications and Background

  • BA/BS and a minimum of 2-5 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in Clinical Supply Management or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained.
  • Solid understanding of pharmaceutical development, manufacturing, packaging, and labeling.
  • Eager to communicate and collaborate with team members across functions including but not limited to: clinical operations, CMC, regulatory affairs, and QA.
  • Working knowledge of cGMP’s (CFR/ICH) and GCP and applicable international regulations/guidelines.
  • Prefer experience working with third-party vendors and contractors, knowledge of QP requirements, and import/export.
  • Global experience with phase 1-4 clinical trials.
  • Experience writing and presenting clearly on clinical supply topics.
  • Ability to work in a virtual environment.

Physical Demands / Travel

The physical demands of this position 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 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 roles and responsibilities 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.


Department:

Clinical Operations and Project Management

Reports To:

Director Clinical Operations

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.

The Clinical Trial Manager functions as the clinical study team leader to plan, organize, and coordinate all operational aspects of a clinical study 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*

  • Prepare and finalize 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.
  • Select investigators and study sites.
  • Identify and respond to site and study related issues and recommending corrective actions and/or escalating to supervisor.
  • Coordinate 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.
  • Ensure that CRF data queries are resolved.
  • Coordinate and manage Investigational Product including overall accountability and reconciliation.
  • Prepare study budgets and timelines.
  • Manage project timelines and vendor performance to meet departmental and corporate goals.
  • 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.
  • 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 with minimal supervision in 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, interacting in a positive and professional manner.
  • Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals.
  • Perform other duties as assigned.

Required Qualifications and Background

  • BA/BS in related field.
  • Minimum 8 years clinical drug development experience.
  • Experience in personnel management.
  • 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.
  • Proficient in MS Office.

Physical Demands / Travel

This position requires approximately 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 based in a typical field and 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 roles and responsibilities 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.


Reports To:

Director, Information Technology

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.

Reporting into the Director of IT, the Cloud Systems Analyst will be responsible for administering, supporting and training end users on Loxo’s various cloud-based applications.

Roles and Responsibilities of the Position*

  • Responsible for the daily operations and support of IT cloud-based applications.
  • Assume system ownership of key cloud-based systems including but not limited to SSO, Box, Zoom, accounting system, spend management system and DocuSign.
  • Communicates all changes, outages and any other cloud system impacts to Director of IT and end users.
  • Identifies areas for improvement by providing recommendations for more efficient IT/business processes within IT systems.
  • Ensures the provisioning of cost efficient information services and systems, while anticipating developments in fields of information technology.
  • Assures that controls, procedures and documentation are up to date and support ISO, SOX, GxP and FDA requirements for IT systems management.
  • Interface with strategic IT application and system vendors.
  • Partner with users of critical business applications to provide guidance and support.
  • Assist staff with hands-on systems management as required.
  • Assist Director of IT with the financial and SOX audit processes.
  • Act as system administrator and expert for multiple cloud-based applications.
  • Perform UAT testing as necessary for financial and GxP systems.
  • Ensures that all documents and other IP are stored in a highly secure environment.
  • Provide web-based, in-person and classroom training to disseminate features and best practices of cloud systems to end users as needed.
  • Partner with Director of IT and business owners with vendor and system selection processes.
  • Maintain strong partnerships with system vendors to ensure best value for the organization.

Required Qualifications and Background

  • At least 5 years of IT experience with a start-up, public and/or Biotech company.
  • Hands on experience in IT, including help desk and end-user onboarding.
  • Experience in system administration such as user management and basic system configuration.
  • Experience in SOX and/or GxP processes.
  • Experience with cloud-based enterprise IT systems (e.g., Box, DocuSign, Veeva, Okta, Intacct, NAV).
  • Experience following and providing feedback for SOPs and policies.
  • Experience conducting training to small or large groups, and creating associated training content.
  • Hands on experience with IT security, such as recommending and applying security settings to IT systems.
  • Demonstrated analytical skills and extremely high attention to detail.
  • Demonstrated strength in oral/written communication and interpersonal skills; team player.
  • Demonstrated organizational skills.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • 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.

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 approx. 10-15% travel as required.

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 roles and responsibilities 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.


Reports To:

TBD

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.

Working with internal business functions as well as outside Counsel, the Contracts Paralegal/Contracts Administrator will be responsible for drafting, negotiating and managing a wide range of contracts such as commercial agreements, professional service agreements, non-disclosure agreements, vendor agreements, etc. as well as provide support on various administrative matters relating to contracts as needed.

Roles and Responsibilities of the Position*

  • Act as point person to triage contract requests.
  • Work with outside Counsel to draft, negotiate and manage a wide range of contracts.  
  • Manage contracts through complete lifecycle of contractual relationships, including contract expirations, renewals, extensions, terminations and amendments, compliance and all associated administrative tasks. 
  • Review, advise and troubleshoot on existing agreements.
  • Define and communicate risks to appropriate internal decision-makers for discussion and resolution.
  • Manage contract template processes including systematic reviews of templates; work with Compliance, outside Counsel, and business functions to ensure that templates are in compliance with legal requirements and best practices
  • Perform administrative tasks specific to contract management, such as creating files, updating files with ongoing correspondence, managing the contract execution process, and scanning and entering executed contracts into internal contract database.

Required Qualifications and Background

  • Associates Degree (or higher) in paralegal studies, Business Law or equivalent discipline or four-year degree in Business, HealthCare, or related field.
  • 5+ years of direct contract experience, preferably in the Biotech/ Pharmaceutical Industry
  • Strong contract drafting, review and analysis skills
  • Ability to manage and meet strict deadlines, as well as support multiple, simultaneous assignments
  • A demonstrated ability to lead change
  • Excellent attention to detail
  • MS Office skills (Outlook, Word, Excel, PowerPoint)
  • Excellent verbal 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 roles and responsibilities 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.


Reports To:

Senior Director, National Diagnostics Lead

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.

As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.

Roles and Responsibilities of the Position*

  • As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
  • Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
  • Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
  • Target, develop, assess and maintain a thorough understanding of accounts and key customers
  • Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
  • Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
  • Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
  • Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
  • Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
  • Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
  • Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
  • 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
  • Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
  • Develop and maintain all account/contact details within Customer Relationship Management database
  • Utilize data analytics and tracking tools to effectively monitor and direct customer activities
  • Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

  • BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
  • Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
  • 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
  • Proven relationships with oncologists and/or pathologists
  • Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
  • Strategic account management experience, including developing & implementing attainable account-specific business plans
  • Excellent listening, time management, organizational and interpersonal skills
  • Must possess strong analytical, negotiation and customer relations skills
  • Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
  • Excited about an early stage company environment that may require greater self-sufficiency
  • Proficient in Microsoft Office suite and applications
  • Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

Please note this role will require 70-80% US travel, primarily within assigned region but also nationally 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 roles and responsibilities 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.


Reports To:

Senior Director, National Diagnostics Lead

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.

As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.

Roles and Responsibilities of the Position*

  • As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
  • Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
  • Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
  • Target, develop, assess and maintain a thorough understanding of accounts and key customers
  • Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
  • Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
  • Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
  • Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
  • Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
  • Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
  • Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
  • 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
  • Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
  • Develop and maintain all account/contact details within Customer Relationship Management database
  • Utilize data analytics and tracking tools to effectively monitor and direct customer activities
  • Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

  • BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
  • Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
  • 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
  • Proven relationships with oncologists and/or pathologists
  • Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
  • Strategic account management experience, including developing & implementing attainable account-specific business plans
  • Excellent listening, time management, organizational and interpersonal skills
  • Must possess strong analytical, negotiation and customer relations skills
  • Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
  • Excited about an early stage company environment that may require greater self-sufficiency
  • Proficient in Microsoft Office suite and applications
  • Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

Please note this role will require 70-80% US travel, primarily within assigned region but also nationally 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 roles and responsibilities 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.


Reports To:

Senior Director, National Diagnostics Lead

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.

As a member of this regionally-based team, the Diagnostics Account Manager (DxAM) will serve as the diagnostics subject matter expert with responsibility for targeted outreach to pathologists, lab directors, oncologists and other account stakeholders to educate on oncology biomarker/genomic testing. The DxAM will leverage account-specific business plans to define opportunities and establish solutions to drive quality testing uptake and identify patients who may benefit from larotrectinib or other targeted therapies. The DxAm may also provide account personnel with appropriate (non-patient specific) education and support around coverage, coding and claims administration of diagnostic testing. Customer segments will focus on academic centers and hospital owned/affiliated community oncology accounts, as well as national and specialty reference labs. Successful DxAMs will work compliantly within the Loxo Oncology commercial organization and in close collaboration with Loxo Oncology and Bayer Oncology Sales, Managed Markets, Marketing, Medical Affairs, MSLs, Account Managers, Clinical Support Specialists, and Legal colleagues. Ideal candidates will possess a depth of knowledge in the oncology market and functional knowledge in the clinical/scientific aspects of cancer diagnosis and biomarker/genomic testing.

Roles and Responsibilities of the Position*

  • As part of a cross-functional, co-promote team, the DxAM will be responsible for cultivating stakeholder relationships and developing account-specific plans to facilitate the uptake of high quality, comprehensive tumor biomarker/genomic testing
  • Master technical and market knowledge related to oncology diagnostic testing (e.g., immunohistochemistry (IHC) and next generation sequencing (NGS)) and how it fits in the treatment paradigm of TRK fusion and other genomically defined tumors
  • Obtain and maintain full proficiency in identified tumor types, disease state, product and business knowledge to support the needs of accounts and the field team
  • Target, develop, assess and maintain a thorough understanding of accounts and key customers
  • Demonstrate knowledge of, access to, and the ability to influence all key stakeholders in targeted accounts (Pathologist, Oncologists, Executive Leadership, Lab personnel, etc.)
  • Identify and communicate customer issues, educational opportunities, and market developments through supervisor and internal partners
  • Develop exceptionally well-designed business plans aligned to diagnostic strategic imperatives with resource allocations that link to strong results
  • Demonstrate a mastery of knowledge and analysis of the oncology diagnostics business and the evolving market landscape
  • Provide (non-patient specific) education & support around coverage, coding and claims administration for oncology diagnostics
  • Institutional account management approach: develop a long-term plan to activate an account (i.e. get buy in for and enable uptake of biomarker/genomic testing) via the various gatekeepers / influencers
  • Liaise with cross-functional and co-promote partners as appropriate to support the establishment of oncology diagnostic testing protocols within accounts
  • 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
  • Facilitate customer hand-off opportunities across the Loxo-Bayer co-promote team, as well as with external (third-party lab and/or IVD company) parties, as appropriate
  • Develop and maintain all account/contact details within Customer Relationship Management database
  • Utilize data analytics and tracking tools to effectively monitor and direct customer activities
  • Adhere to all company and compliance guidelines, policy and procedures

Required Qualifications and Background

  • BA/BS degree in scientific discipline or related field required; advanced degree strongly preferred
  • Strong technical background in molecular biology, genomics, next generation sequencing or immunology a plus
  • 5+ years of successful sales or account management experience in oncology/hematology, biotech, life science or diagnostic sales
  • Proven relationships with oncologists and/or pathologists
  • Well-developed professional and strategic selling skills with a proven ability to grow key accounts by building and leveraging networks inside and outside of key institutions
  • Strategic account management experience, including developing & implementing attainable account-specific business plans
  • Excellent listening, time management, organizational and interpersonal skills
  • Must possess strong analytical, negotiation and customer relations skills
  • Excellent collaboration skills and ability to work independently and as a team member with multiple parties on our Oncology co-promote team.
  • Excited about an early stage company environment that may require greater self-sufficiency
  • Proficient in Microsoft Office suite and applications
  • Experience with effective utilization of Veeva or similar CRM database a plus

Physical Demands / Travel

Please note this role will require 70-80% US travel, primarily within assigned region but also nationally 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 roles and responsibilities 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.


Reports To:

Executive Director, Regulatory Affairs

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.

Responsible for leading the CMC regulatory function, the Director, Regulatory CMC will collaborate cross-functionally to develop the CMC regulatory strategy, provide guidance to broader CMC functions, and drive CMC regulatory filing(s). Working collaboratively with senior leadership to develop CMC regulatory strategies for one or more investigational and/or commercial products this position will lead the preparation and filing of regulatory CMC submissions and manage the interactions with all Health Authorities for CMC topics.  This individual will provide CMC regulatory support and guidance to various cross-functional teams and ensure all applicable regulatory requirements are considered and appropriately incorporated into clinical and commercial products.

Roles and Responsibilities of the Position*

  • Responsible for aiding in the coordination, authorship, preparation, review and timely filing and maintenance of regulatory submissions (INDs, NDAs, CTAs, amendments, safety reports, annual updates, briefing documents, pre-meeting packages, post approval submission and marketing applications to FDA and international regulatory authorities), which support clinical programs, CMC and quality.
  • Provides quality/CMC review for clinical study protocols, clinical study reports, investigator brochures and other relevant reports.
  • Develops and communicates regulatory CMC strategy, identifying key issues and remediation activities needed throughout project/product life cycle.

Required Qualifications and Background

  • Ph.D. or a Master’s degree with 10+ years pharmaceutical industry experience and a minimum of 8 years in Regulatory Affairs.
  • Evidence of successful submissions to FDA (e.g., NDAs, INDs, briefing packages) and demonstrated evidence of writing of regulatory documents.
  • Established working knowledge of regulatory guidelines and regulations (US and international).
  • Regulatory experience supporting both development projects and commercial products.
  • Strong knowledge of eCTD elements and structure and regulatory writing skills.
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • 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 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 position are consistent with light office duties. This position may require 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 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 roles and responsibilities 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.


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.

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)

Required Qualifications and Background

  • RN, BSN or pharmacy degree with at least 3-5 years of industry experience in Clinical Trial Safety; industry experience from CRO or pharmaceutical/biotech setting will be considered.
  • Previous experience in Health care is strongly preferred
  • Hands on experience with SAE case processing including narrative and analysis of similar event (AOSE) writing, and safety report generation.
  • Working knowledge of MedDRA and WHODrug and FDA safety regulations, ICH guidelines, and global safety regulations.
  • Hands on experience with global safety database(s); experience with Argus strongly preferred.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Willing collaborator with strong written and oral communication skills.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Detail oriented and well organized.
  • 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 roles and responsibilities 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.


Reports To:

Executive Director, Discovery Biology

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.

Loxo Oncology’s newly formed Drug Discovery group in Boulder, Colorado has an immediate opening for an experienced Enzymologist. The Loxo Drug Discovery group’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we are building 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 an accomplished Enzymologist. This individual will be a self-motivated, responsible and productive scientist who enjoys collaborating with biologists, chemists and assay scientists. He/she will be responsible for rigorous experimental design, data analysis and data interpretation. The successful candidate will be an enzymology expert who can support small-molecule research teams by developing relevant biochemical assays and characterizing complex enzyme systems and inhibitor mechanisms involved in oncology.

Roles and Responsibilities of the Position*

  • Design and develop novel biochemical microplate assays to identify and characterize small-molecule modulators using a variety of techniques and detection methods, including chromogenic, FP, FRET, TR-FRET, BRET, and ALPHA.
  • Perform enzyme kinetic analyses and MOA studies to characterize biological enzyme systems including kinases.
  • Provide enzymology expertise to discovery project teams at various stages of advancement.
  • Oversee outsourcing of enzyme assays to external CROs and monitor results.
  • Operate automated platforms for liquid handling.
  • Calculate and report assay results to the project teams.
  • Document experiments and results in electronic notebook or database.
  • Provide enzymology perspectives & intellectual support to projects.

Required Qualifications and Background

  • A BS, MS, or PhD in a Life Sciences discipline, with training in molecular biology, enzymology or biochemistry, and a record of lab based independent research experience, minimum of 10+ years for BS, 5+ years for MS and 0-3 years for PhD, either in industrial or academic environment.
  • Experience in mechanistic enzymology.
  • Experience characterizing multiple enzymes using state-of-the-art methods.
  • Must be highly collaborative and able to effectively engage small-molecule research project teams to make rapid progress.
  • Familiarity with techniques and instrumentation relevant to automated plate-based assays
  • 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.
  • Excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes
  • Proficient in Microsoft Office suite and applications.

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 roles and responsibilities 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.


Reports To:

Executive Director, Drug Discovery

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.

Loxo Oncology’s newly formed Drug Discovery group in Boulder, Colorado has an immediate opening for an experienced medicinal chemist. The Loxo Drug Discovery group’s mission is to invent life-changing targeted therapies for cancer patient populations that are poorly treated by existing therapies. To that end, we are building 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 an accomplished Medicinal Chemist with a proven track record of success in small molecule drug discovery. The ideal candidate will be passionate about leading from the bench to solve medicinal chemistry challenges and 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, tactics, 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.
  • Implement and maintain the necessary equipment, processes, software and infrastructure to enable a state of the art medicinal chemistry facility.
  • 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.
  • 5-15+ years of experience in small molecule drug discovery experience in biotechnology or pharmaceutical setting.
  • Proven track record of success in advancing programs from leads to advanced candidates.
  • Extensive experience lead compound optimization in the areas or potency, selectivity, ADME and PK.
  • Highly versed the all current medicinal chemistry instrumentation: HPLC, LC-MS, NMR and purification systems.
  • Expert in using common medicinal chemistry software: electronic notebook, structure drawing, data spreadsheet analysis; 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 roles and responsibilities 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.


Reports To:

Steve Andrews, Executive Director, Drug Discovery

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.

Loxo Oncology is looking for an experienced Scientific Systems Manager to support the growing Discovery Team at our Boulder site. The Scientific Systems Manager’s main responsibility will be implementing and maintaining an electronic notebook (ELN) system across Discovery Biology and Chemistry functions. In addition, this role will be responsible for insuring that additional scientific IT systems are implemented to capture data from collaborators and CROs in a seamless and timely manner while providing the Discovery Team access to the data using a diverse set of visualization tools. To be successful in this role the Scientific Systems Manager will need to have strong communication skills coupled with hands-on experience in database management, ELN implementation and integration of scientific software systems. Strong project management skills will be essential in the role to organize cross-functional activities, ensuring completion of the project while adhering to budget, scope and schedule requirements. This role will serve as an in-house project consultant for evaluating needs and vendor requests for proposals and the Scientific Systems Manager may be required to build tools/products for company internal use.

Roles and Responsibilities of the Position*

  • Communicate and collaborate with the scientific team to understand needs and propose solutions for ELN database management, instrument integration, data access and visualization.
  • Implement and act as system administrator of the team’s ELN.
  • Work with external software providers to implement and customize systems to meet the needs of the scientific team.
  • Project management skills to facilitate onsite implementation of effective processes for generating, analyzing and visualizing data.
  • Train science personnel on scientific computing systems.
  • Establish effective communication and data transfer procedures between Loxo team members and key external collaborators.
  • Evaluate new hardware and software solutions.
  • Experience with Dotmatics and other viable electronic notebook systems.

Required Qualifications and Background

  • B.S. degree in Sciences, IT, Computer Engineering and Project Management experience.
  • Previous track record of scientific notebook platforms implementation at other pharma’s/biotech preferred.
  • 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 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 and 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 roles and responsibilities 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.


Reports To:

Accounting Manager

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.

Based in Stamford, CT, the Senior Account will report to the Accounting Manager and will work directly with a wide range of individuals including senior management, finance team, vendors and other stakeholders. This individual must possess great attention to detail, meticulous organization skills, and a strong desire and ability to work within a dynamic, fast-paced environment with the expectations of the role consistently expanding.

Roles and Responsibilities of the Position*

The Senior Accountant will provide support across multiple areas in the department including: responsibility for improving accuracy and efficiency within our current policies and procedures, accounting for Clinical Trials, account analysis, contract reviews, improved continuation of SOX documentation and maintaining systems and procedures. Additionally, the Senior Accountant will support as needed: bank reconciliation, prepaid expenses, fixed assets, other account reconciliations, accrued expenses, contract administration and financial close responsibilities.

Required Qualifications and Background

  • 4 - 8 Years of experience including recent Clinical Trial and R&D accounting experience Reporting experience
  • Strong analytical and accounting skills with thorough understanding of U.S. GAAP accounting principles and internal control
  • Ability to proactively identify and propose solutions to solve problems
  • Ability to work both independently and part of a team to perform multiple tasks simultaneously
  • Experience working in a SOX controlled environment
  • Strong Excel Skills
  • Cloud based ERP experience a plus

Physical Demands / Travel

The physical demands of this position 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 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 roles and responsibilities 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.


Reports To:

Executive Director, Discovery Biology

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.

The Senior Cell Biologist will play a key role in developing Loxo Oncology’s Drug Discovery group in Boulder, Colorado. The newly created 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 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. 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 and routinely test compounds to support medicinal chemistry lead optimization programs. Establish processes to efficiently and effectively communicate results to the project team.
  • Set-up and maintain laboratory equipment with extensive involvement in equipment evaluation, purchase, installation, testing and IT integration.
  • 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 and cellular systems to test new compounds.
  • 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

  • PhD in Molecular/Cellular Biology, Biochemistry, or related field with 5+ years hands-on molecular biology and cell assay experience in a biotech/pharma setting or BS/MS in Molecular/Cellular Biology or Biochemistry with 10+ hands-on molecular biology and cell assay experience in a biotech/pharma setting.
  • 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, characterizing kinase activity, and technical expertise in molecular biology methods; must be comfortable setting up and maintaining lab equipment and its associated software.
  • 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.

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 roles and responsibilities 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.


Reports To:

Medical Director, Medical Affairs

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.

The Senior Manager, Medical Affairs role will be associated with the strategic planning and tactical execution of the global and US medical affairs activities for early-stage oncology assets. The individual will be responsible for providing medical support across the clinical programs. The Senior Manager, Medical Affairs will be expected to maintain current and evolving literature in oncology and diagnostics through attendance at congresses, interactions with key opinion leaders, and literature review. He/she will also serve as the medical representative on the medical/promotional review committee, which is responsible for review and approval for scientific accuracy of all medical, promotional and educational materials. This individual will work in a highly cross-functional, collaborative environment in preparation for product launch.

Roles and Responsibilities of the Position*

  • Provide tactical execution of the global and US medical affairs activities for early-stage oncology assets.
  • From a project management perspective, review content, and oversee and manage publication timelines, agency selection and medical information content regarding Loxo Oncology’s assets and CDx concordant strategy.
  • Have oversight and responsibility for planning ad boards, Congresses, Symposia and other marketing channels for Loxo Oncology pipeline assets.
  • Support and implement “go to market” strategy to support the CDx launch in collaboration with key stakeholders of the global team (Marketing, Medical Affairs and Market Access leads) and with the external partners.
  • Help to develop a launch tactical plan that will address all dimensions (Sample tissue flow, stakeholder engagement, message development, competitive differentiation) for a successful launch and readiness with a flawless execution of pre-launch and launch activities including performance tracking and analytic plan on KPI.
  • Obtain full alignment between both Loxo Oncology and diagnostic partners and create synergies between the two through execution of respective tactical plans.
  • Monitor the market evolution in terms of new technology of biomarkers and emerging companies in the area of cancer genomics diagnostics and/ or in the translational research efforts of the company.

Required Qualifications and Background

  • MD, PhD, or PharmD required; experience in oncology and/or diagnostics is strongly preferred.
  • 3-5 years of experience in biopharma or medical affairs.
  • Balance long-term strategy while also delivering a tactical execution of day-to-day tasks.
  • Demonstrate an ability to work effectively in multifunctional teams with excellent organizational and communication skills.
  • Comprehend, interpret and deconstruct complex scientific data for various audiences.

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. This role requires up to 25% national/international travel.

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 roles and responsibilities 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.


Reports To:

Director, Accounting

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.

Based in Stamford, CT, the Stock Plan Administrator position is full-time role that reports to the Director, Accounting. This position will be responsible for managing all aspects of Stock Administration for the Company’s equity awards including partnering with key stakeholders in Finance, Legal and HR, as well as external providers including Certent and Morgan Stanley. Responsible as primary contact for all inquiries and requests regarding equity programs and equity transactions. This individual must possess great attention to detail, meticulous organization skills, and a strong desire and ability to work within a dynamic, fast-paced environment with the expectations of the role consistently growing and expanding.

Roles and Responsibilities of the Position*

  • Manage all processing and reporting related to equity awards, including all matters pertaining to the stock administration software, Certent.
  • Process new equity awards and distribute grant agreements as well as handling of cancellations due to terminations.
  • Process daily option exercises including 10b5-1 transactions, ensuring accurate and timely tax withholding and reporting to payroll provider, all the way through to timely settlement of all trades.
  • Manage relationship with stock transfer agent, AST.
  • Ensure new equity awards are properly approved based upon grant guidelines approved by the Compensation Committee of the Board of Directors.
  • Coordinate with outside counsel on preparation and filing of Section 16 reports, brokers and Executive Officers on preparation, amendment, termination and renewal of 10b5-1 plans.
  • Perform monthly, quarterly and yearly reconciliation of records between Stock Administration and HR, Finance, transfer agent, etc. in a timely manner.
  • Generate journal entries associated with stock compensation expense and option exercises.
  • Coordinate with external technical accounting consultant on quarterly stock compensation expense calculations.
  • Work with external auditors and Finance team for quarterly reviews, year-end audits, as well as ensuring tight internal controls are in place and procedures are followed to satisfy periodic review of compliance with Sarbanes-Oxley.
  • Provide support for equity related disclosures in annual and quarterly SEC filings and may assist with project management for annual Proxy preparation.
  • Responsible for annual reporting forms required by tax authorities and year-end tax statements forms required by tax authorities and year-end tax statements.
  • Manage vesting and release of restricted stock units and performance-based restricted stock units, coordinating with payroll provider and external Broker contacts on accurate tax withholding.
  • Develop materials and employee communications; conduct employee trainings.

Required Qualifications and Background

  • At least 4 years in stock plan administration or relevant experience within a SOX controlled environment.
  • Biotech, startup, or pharmaceutical experience a plus.
  • Experience with Certent and/or Morgan Stanley a plus.
  • Experience and ability to work in fast-paced environment.
  • Excellent interpersonal and communication skills (written and oral)
  • Strong organizational skills with amazing attention to detail.
  • Strong IT acumen with ability to work across multiple platforms and paperless AP environments.
  • 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 roles and responsibilities 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.


Reports To:

Executive Director, Drug Discovery

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.

The Toxicologist will be responsible for the planning, execution, and monitoring of DMPK and toxicology studies for advancing candidates through lead optimization, candidate selection and into IND-enabling studies and beyond.

Roles and Responsibilities of the Position*

  • Create novel experimental designs for DMPK and mechanistic toxicology studies designed to assess hypotheses for and evaluate mechanisms of toxicity related to physiological or biochemical functions.
  • Support predictive toxicology experimental efforts within Discovery (e.g., in vitro cell-culture based, animal models of disease) analyze safety-related data and use it to make decisions.
  • Develop early safety assessment, ensure appropriate toxicology studies and liability screens are performed to support nomination of drug candidates for further development.
  • Communicate results clearly and concisely in both oral and written reports.
  • Perform in depth pathway/network analysis on data derived from toxicology and other studies and disseminate results to the wider toxicology community (internally and externally).
  • Closely interact with scientists in other functional areas.

Required Qualifications and Background

  • Ph.D. in toxicology is required, along with 5+ years’ experience as a toxicologist within the biopharmaceutical industry.
  • Previous small molecule oncology therapeutic product development experience in a pharmaceutical or biotechnology company is preferred.
  • Familiarity with GLP regulations and regulatory guidelines for the testing of biopharmaceutical products and experience with compilation of toxicology information into various regulatory submission documents is desirable.
  • 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.
  • 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 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 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 roles and responsibilities 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.


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?