Translational PK PD Director

The Translational PK/PD Director has strong scientific, technical and leadership skills to develop and implement translational PK/PD and modeling & simulation strategies to advance drug candidates from discovery to development. This role is integrated within the Clinical Pharmacology and Pharmacometrics organization. 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 discovery and translational research team and the clinical pharmacology development team. The Director may mentor junior scientists.

Essential Duties/Responsibilities:

• Develop and implement translational PK/PD strategies to drive Exelixis programs from research through early development
• 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 Pharmacology and Pharmacometrics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, 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:

• No Supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• PhD in pharmaceutical sciences, pharmacology or a related discipline and a minimum of 8 years of drug development experience

Experience:

• Minimum 8 years’ experience in translational PK/PD & ADME.
• Experience in development of large molecules and new modalities, including experience with Antibody Drug Conjugates
• Submission of IND/CTAs
• Experience in the Oncology therapeutic area
• Track record of contributions to translational science and precision medicine objectives

Knowledge, Skills and Abilities:

• In-depth understanding of the principles of PK/PD and ADME
• Hands-on modeling and simulation skills. Experience with translational cross-species scaling approaches, PK models, advanced mechanistic PK/PD models and PBPK models is required
• Current knowledge of regulatory guidance related to nonclinical and clinical pharmacology for the different therapeutic modalities
• 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 in the preclinical stage and at the transition from discovery to development 
• 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

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity.  Teams work closely together, sharing ideas and solutions in a supportive atmosphere.  We provide all necessary equipment, including dual monitors and ergonomic workstations, to ensure a comfortable workspace.

Travel requirements can be listed by stating up to certain % of time traveling.

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