Executive Director, Clinical Pharmacology & Pharmacometrics

Summary/Job Purpose (Basic purpose of the job):

The Executive Director, Clinical Pharmacology & Pharmacometrics has strong scientific, technical and leadership skills to develop and oversee 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 will as scientific oversight for the clinical pharmacology support of Exelixis’ portfolio. The Executive Director contributes to growth of the department and will mentor or manage junior clinical pharmacologists.

Essential Duties/Responsibilities:

• Develop, implement and/or supervise clinical pharmacology and pharmacometric strategies to drive Exelixis programs through all the stages from research through post-marketing
• Provide 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 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
• Support functional area reviews for due diligence evaluations
• 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
• Train and mentor junior staff to develop and expand their expertise and encourages them to create innovative solutions that will increase scientific knowledge and technical capabilities

SUPERVISORY RESPONSIBILITIES:

• Supervise staff, including hiring, scheduling, and assigning work, reviewing performance, salary review, promotion, transfer, demotion, or termination.
• Directly supervises full time employees.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• PhD in related discipline and a minimum of 15 years of relevant experience in the pharmaceutical industry; or,
• Equivalent combination of education and experience.

Experience:

• Minimum 15 years experience in clinical pharmacology and pharmacometrics
• Experience in development of small and/or large molecules and new modalities
• Record of supporting drug candidates at various stages of development within the clinical pharmacology function
• Track record in utilization of modeling and simulations to advance drug development
• Submission of IND/NDA/BLA and global marketing applications
• Solid experience in the Oncology therapeutic area
• Contributions to translational science and precision medicine objectives

Knowledge, Skills and Abilities:

• Expert-level understanding of the principles of clinical and quantitative pharmacology  
• Strong quantitative skills including population PK models, advanced mechanistic PK/PD models, disease models and PBPK models
• Deep 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 and deliver effective presentations
• Proven ability to build and lead strong teams
• Ability to communicate and collaborate cross-functionally
• Ability to guide major projects to successful completion
• Ability to adapt, work through conflicts, and persuasively influence outcomes
• Effectively cope with change and is comfortable changing direction and acting without complete information.
• Demonstrated ability to develop and present sound proposals and recommendations and influence and motivate others to achieve objectives
• Thrives in a fast-paced business environment
• Applied knowledge of GLP and GCP regulations
• Function in a highly matrixed team environment
• Establish collaborative networks between functional areas
• Find creative solutions to unique and complex problems

Work Envir