Clinical Pharmacology & Pharmacometrics Director

Role Summary

The Clinical Pharmacology & Pharmacometrics Director has strong scientific, technical and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of the development. Working closely with partners from discovery and development, the individual is responsible for providing strategic and technical subject matter expertise as a member of the project development team. The Director contributes to growth of the department and may mentor or manage junior clinical pharmacologists.

Responsibilities

• Develop and implement clinical pharmacology and pharmacometric strategies to drive Exelixis programs through all stages from research through post-marketing.
• Serve as the clinical pharmacology/pharmacometrics lead on project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions and quantitative pharmacology.
• Progress small molecules and biologics through development milestones including IND/CTA, EOP2 and marketing applications.
• Oversee and/or conduct PK/PD and exposure-response analyses using relevant state of the art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions and publications.
• Work collaboratively with functional partners including Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations and Regulatory to deliver on project and corporate objectives.
• Drive external scientific visibility and publication objectives.
• Work with internal and external scientific experts to evaluate new methods to maintain cutting edge techniques, models, and capabilities.
• Assure the implementation and adherence to SHE policies, GXPs compliance, and regulatory standards in the clinical pharmacology programs.

Supervisory Responsibilities

• Mentor and may supervise 1 or 2 regular employees.

Education

• PhD or PharmD in pharmaceutical sciences, pharmacology or a related discipline and a minimum of 8 years of drug development experience; or,
• Equivalent combination of education and experience.

Experience

• Minimum 8 years experience in clinical pharmacology and pharmacometrics.
• Experience in development of small and/or large molecules and new modalities.
• Submission of IND/NDA/BLA and global marketing applications.
• Experience in the Oncology therapeutic area is preferred.
• Contributions to translational science and precision medicine objectives.

Knowledge, Skills And Abilities

• In-depth understanding of the principles of clinical and quantitative pharmacology.
• Hands-on modeling and simulation skills using NONMEM, R and/or other modeling and simulation software. Experience with population PK models, advanced mechanistic PK/PD models, disease models, PBPK models is highly preferred.
• Current knowledge of regulatory guidance related to nonclinical and clinical pharmacology for small molecules and biologics.
• Excellent interpersonal, verbal and written communication skills and the ability to convey complex technical information clearly.
• Ability to communicate and collaborate cross-functionally.
• Record of supporting drug candidates at various stages of development within the clinical pharmacology function.
• Demonstrated impact on drug development decisions through quantitative approaches with strong leadership skills and the ability to influence.
• Ability to develop and deliver effective presentations and written/oral communications.
• Thrives in a fast-paced business environment.
• Applied knowledge of GLP and GCP regulations.
• Function in a highly matrixed team environment.
• Find creative solutions to unique and complex problems.