Senior Director – Clinical Pharmacology & Pharmacometrics

Senior Director – Clinical Pharmacology & Pharmacometrics

Requirements

• PhD in related discipline and a minimum of 12 years of relevant experience in the pharmaceutical industry; or, Equivalent combination of education and experience.
• Minimum 12 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
• Experience in the Oncology therapeutic area is preferred
• Contributions to translational science and precision medicine objectives
• 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
• 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

Responsibilities

• Develop, implement and/or supervise clinical pharmacology and pharmacometric strategies to drive Exelixis programs through all the stages from research through post-marketing
• Serve as the clinical pharmacology lead on several 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
• 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

Preferred Qualifications

• Experience in the Oncology therapeutic area is preferred
• Contributions to translational science and precision medicine objectives