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:

Head, CMC

Position Summary

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

The Loxo Oncology at Lilly chemical manufacturing controls (CMC) team has an immediate opening for an Associate Director of Analytical Chemistry. The individual will be responsible for all aspects of analytical testing and cGMP manufacturing operations, including oversight of laboratory development work and analytical testing at external research, development, and manufacturing organizations (CDMOs).

Loxo Oncology at Lilly is looking for an independent self-starter to lead method development, method transfers, method qualifications/validations, and IND stage molecules into phase I/II clinical trials. This individual will be responsible for troubleshooting drug substance and drug product analytical issues that arise during development and the preparation of technical reports and drug product sections of CMC regulatory submissions.

Roles and Responsibilities of the Position*

  • Work collaboratively with process chemistry, pharmaceutics, medicinal chemistry, DMPK, toxicology, pharmacology, CMC regulatory, and clinical development to support the delivery and release of test articles for different phases of animal and human studies
  • Manage technology transfer and qualification/validation of analytical methods to support starting material, intermediate, drug substance and drug product testing at CMOs/CTOs
  • Author and review technical documents, analytical development reports, and drug product sections for IND, IMPD and global marketing applications
  • Proactively identify ways in which research and manufacturing objectives can be achieved on expedited timelines while advancing multiple risk mitigation strategies in parallel
  • Manage multiple projects, set priorities, and work in a fast-paced environment
  • Collaborate with CMC and regulatory colleagues to establish and justify specifications for drug substances, starting materials, intermediates and drug products
  • Review and approval of analytical results, protocols and reports
  • Support evaluation of packaging configurations of oral solid dosage forms
  • Collaborate with QA, CMC team and CMOs towards timely generation and approval of documents
  • Other duties as assigned

Required Qualifications and Background

  • Ph.D. in analytical chemistry or related discipline with 8-10 years experience, or Master’s with 10‑12 years of experience, or a Bachelor’s degree with 13-15+ years pharmaceutical industry experience and a minimum of 8 years in a pharmaceutics and formulation development organization
  • Requires a strong background in analytical method development, applying analytical techniques to solve challenging problems, experience in IND-enabling and clinical stability study design/management
  • Demonstrated proficiency in both hands-on analytical work, managing activities, reviewing and organizing analytical data and solving analytical challenges at third party pharmaceutical manufacturers
  • Experience authoring and reviewing technical documents including, but not limited to, development reports, master batch records, analytical testing methods, and specifications
  • Well-versed on global regulatory requirements for the manufacture, testing, and control of clinical and commercial drug substance and drug products and able to apply this knowledge to manufacturing strategy to control quality attributes of drug products   
  • Experience in drafting CMC sections of INDs, IMPDs, and marketing applications, and practiced in responding to inquiries from regulatory agency review
  • Experience with CROs, CMOs and CDMOs
  • Expert knowledge of the USP, regulatory, ICH and cGMP requirements
  • Experience in late stage drug development
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
  • Strong written and oral communication skills
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Detail oriented and well organized
  • Good and thoughtful listener
  • Enthusiastic, self-motivated, and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Senior Biochemist

Position Summary

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

This position is an opportunity to learn and grow within a dynamic structural biology team dedicated to creating specific targeted therapeutics for genetically defined oncology targets. The Associate Protein Biochemist will provide highly purified protein reagents that aid in the evaluation of protein ligand complexes.

Roles and Responsibilities of the Position*

  • Rapidly express and highly purify recombinant proteins from a variety of cell sources to support protein structural and biophysical/biochemical studies
  • Collaborate with colleagues throughout the company to ensure reagents meet experimental demands
  • Adapt to highly dynamic project priorities, with diligent and rapid communication of scientific results and insights to the team
  • Participate in discussions with vendors for outsourced services and studies
  • Learn and develop technical expertise in protein biochemical and biophysical characterization
  • Develop and continually advance one’s knowledge base on genetically targeted drugs and structure-based drug design

Required Qualifications and Background

  • BA/BS, MS, PhD in Biochemistry, Chemistry, or related field
  • Ideal candidate will have 2+ years hands-on protein expression and purification experience in a biotech/pharma setting.
  • Some experience in protein construct design, cloning, and basic molecular biology principles
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels.
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Committed to staying current with the latest scientific breakthroughs in structure-based drug design and structural biology.
  • Expertise in other methods of enzymology or biophysical characterization and structural biology is a plus

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Senior Director, Biostatistics

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in an office. 

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

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

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


Reports To:

Senior Director, Bioassay Screening

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

  • BS/MS in biology, biochemistry or related fields
  • 2-8 years of experience culturing cells and performing cell assays in biotech or a pharma environment
  • A scientific foundation in the understanding and implementation of a wide range of cell-based screening assays and readouts
  • Excellent oral and written communication skills including experimental documentation
  • Works well with team members daily across functional areas
  • Continual learner who works independently and possesses a can-do attitude
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines
  • Highly organized with exceptional attention to detail
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in a lab.  

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

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

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


Reports To:

Senior Manager, Clinical Data Management

Position Summary

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

The 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 Oncology at Lilly regulatory and legal policies.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 Oncology at Lilly 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

  • Bachelors’ 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 hematology/oncology experience required.
  • 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 role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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


Reports To:

Senior Director, Business Operations

Position Summary

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

The Contracts Paralegal/Administrator will be working with internal business functions as well as the legal team. This individual will be responsible for drafting, negotiating and managing contracts, including vendor and non-disclosure agreements, as well as providing support on various administrative matters related to contracts as needed. 

Roles and Responsibilities of the Position*

  • Help draft, negotiate and manage a wide range of contracts
  • Identify and mitigate business risks throughout the contracting process
  • Manage the lifecycle of contracts, including contract expirations, renewals, extensions, terminations, and amendments
  • Perform administrative tasks specific to contract management, such as creating files, updating files with ongoing correspondence, managing the contract execution process, and entering executed contracts into the 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 or Diagnostics Industries
  • Strong contract drafting, review and analysis skills
  • Ability to manage and meet strict deadlines, as well as support multiple, simultaneous assignments
  • 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 role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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


Reports To:

Senior Clinical Trial Manager

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. This role can require up to 40% domestic and international travel. 

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

Work Environment

This position’s work environment is in an office. No specific work demands.

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

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

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


Reports To:

Senior Director, Medical Affairs

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Senior Medical Director, Medical Affairs

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Head, CMC

Position Summary

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

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Senior Director, Drug Safety

Position Summary

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

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in an office.

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

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

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


Reports To:

Senior Director, Bioassay Screening

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in a lab. 

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

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

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


Reports To:

Associate Medicinal Chemist

Position Summary

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

The Lab Operations Coordinator will support a robust Discovery Lab environment through sample preparation, sample organization and tracking, data entry, safety maintenance, and additional responsibilities as needed. The Lab Coordinator will possess excellent information management skills as well as the ability to communicate, explain, interpret, and share information in order to best support the Discovery team.

Roles and Responsibilities of the Position*

  • Implement and maintain an inventory system for laboratory samples and manage sample storage on-site.
  • Prepare samples for testing in biological assays and coordinate sample delivery between lab and external vendors both US and globally.
  • Implement and maintain an inventory system for chemical reagents.
  • Maintain complete, accurate, and organized file systems.
  • Routinely order commonly used chemicals and laboratory supplies.
  • Contribute to the upkeep and safety of the laboratory and assure a clean, safe, adequately supplied work area.

Required Qualifications and Background

  • Associates or Bachelor’s degree in the Life Sciences preferred, but will also consider high school diploma and relevant experience.
  • 2+ years' direct industry experience in a lab or sample management related role.
  • Understanding of safe laboratory practices.
  • Proficient in Microsoft Office.
  • Strong attention to detail and communication skills.
  • Demonstrated ability to work well with other scientists within and across functions/teams.
  • Willing collaborator.
  • Enthusiastic, self-motivated and keen to improve process efficiencies.

Physical Demands / Travel

The physical demands of this job are consistent with working in a wet-laboratory setting.  Requires ability to lift up to 15 lbs.

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

Work Environment

This position’s work environment is in a lab.

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

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

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


Reports To:

Senior Director, Business Operations

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in an office.

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

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

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


Reports To:

Director, Clinical Supply Management

Position Summary

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

The Specialist/Manager, Clinical Supply Management will support Clinical Supply Management by conducting various work streams with internal and external team members for the on-time delivery of clinical supplies across the Loxo Oncology at Lilly portfolio.

Roles and Responsibilities of the Position*

  • 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 oncology portfolio.
  • Update and maintain study supply plans including drug supply forecasts for manufacturing, packaging, and labeling operations.
  • Provide oversight of packaging and distribution collaboration partners 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. Ensures 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/IWRS 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 3-5 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 role and responsibility satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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


Reports To:

Executive Director, Quality Assurance

Position Summary

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

The Manager, Quality Assurance is responsible for all aspects of Quality Assurance and GCP compliance. The Manager 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, and work closely with the Clinical Operations team. The Manager, 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.

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
  • Reviews and approves Quality Events and associated Corrective and Preventative Actions within a regulated Quality Management System
  • Represents GCP expertise and acts as the QA point person on cross-functional clinical study teams
  • Keeps current with global health authority laws and regulations and implements process improvements resulting from new/revised regulations or guidance
  • Reviews study team documentation as requested (e.g. Data Management, Operations, Safety, Regulatory, etc.)
  • Liaises audit requirements between clinical study teams and auditing group and follows up on audits with the auditee
  • Utilizes the Loxo Quality Systems to manage Quality system elements
  • Drives inspection readiness activities for project teams
  • Supports external Health Authority inspections

Required Qualifications and Background

  • Bachelor’s degree with 10 or more years’ experience working in either a clinical compliance or clinical Quality group
  • Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
  • Demonstrated Issue Management and CAPA experience in a clinical environment
  • 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
  • Good problem solving, written and verbal communication skill
  • Ability to effectively manage multiple priorities with a sense of urgency
  • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
  • Attention to detail and accuracy of work
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams
  • Willing collaborator
  • 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
  • Critical thinker and solution oriented
  • Enthusiastic, self-motivated and self-starter

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 / lab / traveling in the field

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

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

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


Reports To:

Senior Manager, Talent Acquisition

Position Summary

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

The Senior Recruiter/Manager, Talent Acquisition will play a pivotal role in our growing organization. Based in our South San Francisco office, this individual will manage full life cycle recruitment for open requisitions, while assisting in further developing recruitment processes. In collaboration with Human Resource partners, Leadership and Hiring Managers the Senior Recruiter will focus on establishing skill requirements, background and experience needed, for open requisitions across Discovery, Pre-clinical and Early-phase clinical development. Further, the Senior Recruiter will be tasked with telling the Loxo story with an emphasis on culture and our guiding principles of strong science coupled with patient focus.

Roles and Responsibilities of the Position*

  • Partner with the HR team and hiring managers to define roles and strategize recruitment plans. 
  • Manage end-to-end recruiting including sourcing, screening, interviewing, and offer generation.
  • Build strong relationships with hiring managers that include regular status meetings and diligent follow through in order to influence and guide hiring managers in recruiting top talent.
  • Understand market conditions for targeted sources and prepare distinct and effective recruiting approaches to those markets.
  • Establish and manage external agency relationships inclusive of contingent, retained and temporary search firms.
  • Develop, track and analyze talent acquisition metrics to make informed decisions and ongoing process improvements.
  • Provide candidates with a best in class experience, maintaining contact, responsiveness and transparency throughout the recruiting process ensuring a high level of candidate engagement and positive overall experience.  
  • Work with HR Business Partners and leadership, to anticipate and prioritize recruitment efforts across the organization in order to proactively support business needs.

Required Qualifications and Background

  • BA/BS degree required along with 5-7 years of industry recruiting experience with a proven track record of sourcing and recruiting in the Biotech/Life Sciences market required.
  • Possess strong assessment skills to reveal candidate's technical background, business capabilities and EQ.
  • Capable of driving and owning the TA process to meet business needs while ensuring candidate and hiring manager satisfaction. 
  • Passionate, high-energy, accountable, and collaborative team player with the ability to prioritize and multi-task.
  • Possess proven relationships and an extensive network across the Bay area.
  • Strong communication and interpersonal skills, with the ability to build professional relationships across all levels of the business
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in an office.

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

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

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


Reports To:

Vice President, Small Molecule Biology

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

  • PhD in Biochemistry, Chemistry, Molecular/Cellular Biology or related field with 8+ years hands-on biochemistry or biophysics experience in a biotech/pharma setting OR BS/MS in Biochemistry, Chemistry, Molecular/Cellular Biology or related field with 12+ years hands-on biochemistry or biophysics experience in a biotech/pharma setting
  • Demonstrated experience supervising 2 or more scientists
  • Strong background in enzymology and experimental curve-fitting and statistics
  • Proven track record in design and development of state-of-the-art biophysical methods including, but not limited to; Surface Plasmon Resonance (SPR), Isothermal Titration calorimetry (ITC), Protein small molecule binding/activity assays, mass spectrometry, and protein/protein interaction analysis
  • Excellent interpersonal skills with ability to communicate and interact well with colleagues, vendors, contractors, scientific advisors, and staff at all levels
  • Highly organized with excellent analytical, documentation and multi-tasking skills
  • Committed to staying current with the latest scientific breakthroughs in the targeted oncology field from target identification through human clinical trials
  • Good and thoughtful listener who values collaboration
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies
  • Proficient in Microsoft Office suite and applications

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in a lab.

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

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

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


Reports To:

Chief Medical Officer

Position Summary

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

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

Roles and Responsibilities of the Position*

  • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents.   
  • May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with research colleagues to design and implement translational strategies.
  • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Loxo at key external meetings.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. 

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Associate Director, Drug Discovery

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Associate Director, Clinical Science

Position Summary

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

This position offers the opportunity to participate in the entire spectrum of the drug development process. We design our drugs “from the ground up”, starting with the selection of a target we hypothesize is critical for cancer survival and producing a highly potent and specific inhibitor of that single target. As the Senior Clinical Scientist, you will have the opportunity to not only move this drug “from the bench to the bedside”, from initial planning of the first-in-human clinical trial to the pivotal studies necessary to prove its clinical efficacy and gain regulatory approval but also lead a team of Clinical Scientists. You will participate directly in improving the lives of people fighting their cancers.

Roles and Responsibilities of the Position*

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

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

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

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

Required Qualifications and Background

  • PharmD, PhD or MD or MSN in Nursing.
  • The ideal candidate will have 7 years of biopharma experience in an academic or industry setting and at least 2+ years’ medical/clinical scientist experience in oncology. At least 7 years’ clinical research experience preferred, particularly in drug development in oncology and/or hematology (specifically B-cell leukemias and lymphomas malignancies such as CLL and mantle cell lymphoma).
  • Clinical trial expertise along with experience in oncology/hematology with drug development highly desirable. Must possess a strong background in clinical trials in an academic or industry setting.
  • Extensive academic/industry experience in laboratory-based cancer research or clinical trials is preferred.
  • The skills required for success in the job include scientific and analytic ability, ability to think strategically and tactically, an interest in applied clinical research, an ability to work effectively in multifunctional teams and excellent organizational and communication skills.
  • The candidate must demonstrate proven ability to evaluate, interpret and present complex scientific data to both technical and non-technical audiences.
  • Demonstrated ability to work well with other accomplished professionals within and across functions/teams. Willing collaborator.
  • Strong communication skills both written and oral.
  • Ability to multi-task and shift priorities rapidly to meet tight deadlines.
  • Professional demeanor and appearance and an excellent written and verbal communicator.
  • Detail oriented and well organized.
  • Good and thoughtful listener.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Proficient in Microsoft Office suite and applications.

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in an office.

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

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

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


Reports To:

Head, Compliance

Position Summary

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

Loxo Oncology at Lilly, (“Loxo”) is developing a world-class compliance program. We seek an individual to work with the Head of Compliance at Loxo to help  establish and integrate the company’s Ethics & Compliance function to enhance the company’s strong culture of compliance. Reporting directly to the Head of Compliance at Loxo, this individual will work collaboratively and strategically to drive a culture of ethics, integrity and compliance across the Loxo organization. In this role, you will have the opportunity to partner with all area of the business, at all levels of the organization and with Eli Lilly affiliates.   

This role will assist in developing and implementing policies and procedures, compliance training and communications, auditing and monitoring, internal reporting, compliance-related investigations and other initiatives to continuously improve Loxo’s Ethics & Compliance Program.  This will include implementation and integration of Loxo’s Helpline, investigation process, engagement of health care professionals, Transparency & Disclosure obligations, Anti-Bribery Anti-Corruption program, privacy and Global Data Protection Regulations (GDPR) matters and other compliance projects and initiatives.

Roles and Responsibilities of the Position*

  • Work closely with Head of Compliance on various initiatives including development of key compliance program elements and across all areas of the business including research, development, medical affairs and other business functions
  • Draft, revise and integrate compliance policies, SOPs, guidelines, and associated internal communications and training plans related to key areas of risk relevant to global pharmaceutical companies and specifically research, development and medical affairs
  • Design and deliver compliance-related training, including new hire training and policy related training for medical field-based and home office personnel
  • Integration of the company’s state and federal aggregate spend reporting and disclosure obligations, including implementation of the appropriate systems, policies and procedures
  • Conduct compliance monitoring activities to prevent, monitor and detect compliance-related issues
  • Provide compliance and policy guidance to business partners
  • Perform or collaborate in performing investigations of potential compliance issues
  • Assist with compliance programs such as Anti-Bribery Anti-Corruption/FCPA and Privacy/GDPR compliance  
  • Maintain high level of knowledge of current and emerging laws and regulations and recent enforcement actions and inform and educate business units with tailored communications and relevant training

Required Qualifications and Background

  • Candidates should have strong academic credentials and 5-7 years of experience in compliance, preferably with prior pharmaceutical or device company or in another health science industry or setting
  • Knowledge of business and operations of pharmaceutical company, device manufacturer or related health industry
  • Compliance experience related to research, development and medical affairs areas is a plus
  • Knowledge of relevant laws and regulations specific to health care industry including False Claims Act, Anti-Kickback statute, FCPA, FDA rules on promotion, PhRMA and other industry codes
  • Demonstrated experience in implementing some or all compliance program elements such as policies and procedures, compliance training, auditing and monitoring, investigations
  • Strong verbal and written communication skills
  • Ability to work well cross-functionally, across multiple areas of the business and at all levels
  • Self-starter and must be able to work independently with minimal supervision
  • Compliance business partner mindset to assist business in achieving goals in a compliant manner
  • Good project management skills and can bring a project to completion in collaboration with multiple functional areas
  • Articulate with good presentation skills and able to deliver training and clear compliance guidance
  • Enthusiastic and passionate about the work that we do
  • Ability to multi-task and handle multiple topics
  • Detail oriented and well organized

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 may involve occasional traveling in the US.  

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

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

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


Reports To:

Associate Director, Medicinal Chemistry

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

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


Reports To:

Director, Translational Medicine

Position Summary

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

With their background in cancer biology, the Senior Scientist, Translational Medicine will lead and support translational research projects associated with Loxo Oncology at Lilly’s  preclinical and early development programs. This entails formulating and executing plans aimed at characterizing our lead compounds, including their: (1) efficacy (in vitro and in vivo), (2) mechanism of action, (3) target patient populations, and (4) biomarkers predicting clinical response. It may also involve developing prototype clinical diagnostic tests for promising biomarkers. The successful candidate will achieve these objectives by collaborating with Loxo Oncology at Lilly’s discovery scientists, evaluating and initiating new collaborations with academic institutions, identifying & overseeing research at CROs and working closely with their clinical development colleagues at Loxo Oncology at Lilly.

Roles and Responsibilities of the Position*

  • Design and execution of cancer cell line and xenograft studies assessing compound efficacy
  • Engineering of knock-in & knockdown cell lines with CRISPR and/or other technologies
  • High throughput siRNA and/or CRISPR screens of cell lines
  • Extraction of DNA, RNA & proteins, particularly from FFPE samples
  • RT-PCR and NGS assays of RNA abundance, CNVs and/or SNVs
  • IHC, Western blot, ELISA and mass spectrometry assays of protein abundance
  • FISH assays of chromosomal abnormalities
  • Utilize animal models for immune-oncology, inflammation, or autoimmunity research
  • Immunology/auto-immunity assays, including immune cell isolation and characterization using flow cytometry
  • Design and execution of cross-assay validation studies
  • Management of internal and/or CRO-based bench scientists
  • Management of academic sponsored research
  • Organization and coordination of multiple projects in parallel
  • Preparing and presenting scientific results at congresses and in peer-reviewed journals

Required Qualifications and Background

  • Ph.D. in a biological discipline with  8+ years of bench experience. Post-doctoral research and/or industry experience preferred
  • Extensive research experience in solid tumor and/or heme oncology
  • Demonstrated ability to evaluate the mechanism of action of compounds, to identify biomarkers, and to translate findings to relevant assays for clinical research
  • Familiarity with clinical trial design and the implementation of biomarker strategies
  • 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

Physical Demands / Travel

The physical demands of this job are consistent with light office duties. Up to 15% travel required for this role.

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

Work Environment

This position’s work environment is in an office.

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

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

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


Reports To:

Director, Statistical Programming

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

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

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

Work Environment

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

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

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

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


Reports To:

Executive Director, Quality Assurance

Position Summary

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

The Specialist, Quality Assurance - GMP supports quality systems at Loxo Oncology at Lilly and those of contract manufacturing, testing, research and/or laboratory organizations. The Specialist, Quality Assurance - GMP will function as a QA Generalist and will work closely with Loxo Oncology at Lilly and Contract Organizations, QA and CMC colleagues.

Roles and Responsibilities of the Position*

  • Ensure GMP work at Loxo Oncology at Lilly and contract organizations is done in compliance with applicable laws, regulations and guidelines
  • Work closely with internal and external QA and CMC colleagues through all phases of drug development, particularly early phase
  • Execute all Quality system elements, which include but are not limited to investigation of product complaints, deviations, OOS investigations, document creation and control, site audits, change control, validation (e.g. process, cleaning, analytical method, etc.), stability, batch record review, and product disposition
  • Participate in the review, evaluation and approval of technical documentation related to GMP manufacturing, labeling, packaging, and testing
  • Facilitate documentation reviews with Qualified Persons (QPs)
  • Review and approve drug product labeling
  • Support QMS management and maintenance for GMP activities, which includes, but is not limited to writing and revising SOPs, maintaining training records, and managing deviations, CAPAs, audits, etc.
  • Support QA project leads and participate on project teams and sub-teams as needed and assigned
  • Ensure documents and records are kept in compliance with regulations and SOPs

Required Qualifications and Background

  • BA/BS in science or engineering
  • A minimum of 5-7 years of experience working in a Biotech or Pharmaceutical FDA regulated industry in QA or a related field or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
  • Experience working with solid oral and liquid dosage forms
  • Ability to multitask and work in a fast-paced environment
  • Ability to work in a matrixed environment
  • Working knowledge of cGMP’s (CFR/ICH) and applicable international regulations/guidelines
  • Experience working with outside vendors and contractors
  • Strong understanding of GMP requirements for early phase drug development
  • Ability to work in a virtual manufacturing environment
  • Ability to travel both domestic and internationally
  • 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
  • Attention to detail and accuracy of work

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, manufacturing facility.

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

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

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


Reports To:

Executive Director, Quality Assurance

Position Summary

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

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

Roles and Responsibilities of the Position*

  • Provides support to QA Program Manager in overseeing the Loxo GXP Quality systems such as document management, change control, deviations, CAPA’s, training, internal/external audits, etc.
  • Supports lifecycle management of Quality documentation (e.g. SOP’s, Deviations, CAPAs, training records, audit reports, etc.)
  • Tracks and trends Quality system element status and performs follow up as needed
  • Supports the Loxo training program which includes assisting in curricula development and approval and management of employee training files
  • Collaborates with IT and QA Program Manager to problem solve system related issues
  • Supports inspection readiness activities by accessing and providing Quality system documentation
  • Works with internal departments to ensure continuous improvement of processes / procedures and quality of work product

Required Qualifications and Background

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

Physical Demands / Travel

There are no specific physical demands for this position. 

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

Work Environment

There are no specific work demands for this position. 

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

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

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


Reports To:

TBD

Position Summary

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

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

Roles and Responsibilities of the Position*

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

Required Qualifications and Background

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

Physical Demands / Travel

There are no physical/travel demands for this job.

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 equally in a wet lab and office environment. 

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

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

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


Reports To:

Director, CMC

Position Summary

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

Our CMC team is in immediate need of a Supply Chain Logistics Coordinator. This individual will be responsible for managing and maintaining all aspects of drug production and distribution. 

Roles and Responsibilities of the Position*

  • Manage all aspects of moving materials including raw materials, starting materials, drug substance, bulk drug product, and samples from and to collaboration partners
  • Manage processes related to all third-party supply chain collaboration partners ensuring accurate and GxP compliant product receipt, storage, and distribution
  • Prepare and review collaboration partner specific shipping documentation
  • Maintain detailed records of shipment requests and all shipping documentation (i.e. pack lists, BOLs, pro forma invoices, temperature data, A1A packets, etc.)
  • Track and drive process from order to delivery at final destination, notification to recipient of incoming shipment, maintaining performance metrics on collaboration partner (i.e. ability to ship on requested date, temperature excursion or damage, etc.)
  • Determine preferred logistics partners such as FedEx custom critical, World Courier, etc. by analyzing performance and cost
  • Create a product database maintaining harmonization codes, unit costs, customs statements, etc. for all material movements
  • Update and maintain inventory and shipping records

Required Qualifications and Background

  • BA/BS in scientific discipline
  • Proven experience in a logistics or operations role in the pharmaceutical, biotechnology or other highly regulated industry or an equivalent combination of education, training and/or experience from which comparable knowledge, skills and abilities have been attained
  • Working knowledge of cGMP’s (CFR/ICH), GDP, and applicable international regulations/guidelines including global import/export regulations
  • Ability to organize information for easy retrieval
  • Eager to communicate and collaborate with team members across functions including but not limited to: CMC, Clinical Supply Management, and QA
  • Work well in a team environment with shared responsibilities and a virtual environment

Physical Demands / Travel

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

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

Work Environment

This position’s work environment is in an office.

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

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

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


Position

Outstanding Team Member

Location

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

Position Summary

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

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

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

Connect With Us

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

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

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

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