Associate Clinical Pharmacology & Pharmacometrics Director

Role Summary

The Associate Clinical Pharmacology and Pharmacometrics Director has strong scientific, technical and leadership skills to contribute to development and implementation of 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 subject matter expertise as a member of the project development team.

Responsibilities

• Develop and implement clinical pharmacology and pharmacometrics strategies to drive Exelixis programs through all the stages from research through post-marketing.
• Serves 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.
• 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.
• 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.

Qualifications

• PhD or PharmD degree in pharmaceutical sciences, pharmacology or a related discipline and a minimum of 5 years of relevant drug development experience; or,
• Equivalent combination of education and experience.
• Minimum 5 years experience in clinical pharmacology and/or pharmacometrics.
• Experience with development of small and/or large molecules and new modalities.
• Contributions to translational science and precision medicine objectives.

Skills

• 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.
• 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.
• Strong scientific 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.

Education

• PhD or PharmD degree in pharmaceutical sciences, pharmacology or a related discipline and a minimum of 5 years of relevant drug development experience; or,
• Equivalent combination of education and experience.

Additional Requirements

• None.