Translational Medicine Director

SUMMARY/JOB PURPOSE:

In collaboration with clinical, discovery, clinical pharmacology, and other functional teams of the company, this role serves as the translational medicine/science lead and provides translational support for early and late stage development studies. Duties include performing pharmacodynamics and biomarker analyses for preparation of study documents and publications. This individual must have experience in oncology, immunology, and molecular biology and must have experience in clinical drug development. Experience in biologics and small molecule clinical drug development, and immunological based assays, and having experience with translational biomarker assays is required.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

1. Function as a Translational liaison with R&D teams during early stage development.
2. Function as a Translational medicine lead for Exelixis sponsored clinical studies participating in relevant program and project teams from early stage development and pre-IND through clinical development.
3. Serve as a Translational representation in clinical trial teams during clinical development.
4. Establish clinical biomarker strategies for assigned company sponsored clinical trials.
5. Manage development and implementation of biomarker assays into company sponsored clinical trials.
6. Serve as translational subject matter expert for clinical protocol and informed consent development, review and amendments for relevant company sponsored clinical trials.
7. Participate in development and implementation of translational/pharmacodynamic/biomarker and other relevant assays into company sponsored clinical trials.
8. Analyze integrated translational datasets from company sponsored clinical studies for presentations and publications in a collaborative team environment.
9. Maintain a working relationship with clinical pharmacology and bioanalytical and toxicology teams and provide support for internal stakeholders (i.e., Non-Clinical and Clinical Development) for program/project specific areas.
10. Devise and conduct preclinical studies as needed to inform and facilitate development strategy.
11. Participate in training of clinical study sites during site initiation visits and investigator meetings.
12. Responsible for ensuring timely procurement and distribution of clinical trial samples for analysis.
13. Collect knowledge of the research and development efforts from relevant academic institutions, competitor pharmaceutical companies, and fee-for-service bioanalytical companies.

SUPERVISORY RESPONSIBILITIES:

• None.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• PhD in related discipline and a minimum of 8 years of related experience; or, equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

• A minimum of 12 years of experience in the biotechnology or pharmaceutical industry or the equivalent combination of education and industry experience preferred.
• Experience in clinical oncology studies with molecular targeted and biologic therapies.
• Experience with various biomarker assays (e.g. immune based assays, flow cytometry, IHC, genomic and expression, etc.).
• Excellent communication skills (written and oral).
• Good foundation and experience in providing presentations of scientific overviews and data in appropriate context for various types of meetings (internal and external).
• Embrace opportunities to learn and adapt to various processes that may be situation specific.
• Ability to work independently.

Knowledge/Skills:

• Ability to integrate principles of Good Clinical Practice and Good Laboratory Practice into clinical trial design.
• Understanding of informed consent process in clinical trials as it applies to sample collection for translational medicine studies.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Understanding of successful completion of translational projects and preparation of project-related publications.
• Has good understanding and application of technical principles, theories, concepts and techniques related to immunological processes.
• Excellent prioritization and time management skills to facilitate timely delivery of all tasks.
• Excels at being a team player, works well with TM team members and promotes the collaborative work environment within the TM team.
• Has good general knowledge of other related disciplines.
• Strong interpersonal skills.
• Applies strong analytical and communication skills.
• Excellent public speaking and presentation skills.

JOB COMPLEXITY:

• Has an in-depth knowledge of the functional area.
• Coordinates with cross-functional groups in project development areas.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.

WORKING CONDITIONS:

• Travel to conferences and seminars as needed.

#LI-HG1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $166,500 - $236,000 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.