Executive Director, Clinical Pharmacology
Overview
An innovative and well-funded clinical-stage biopharmaceutical company, is seeking an accomplished Executive Director of Clinical Pharmacology and Pharmacometrics. This is a unique opportunity to join a passionate and experienced team dedicated to advancing oncology therapeutics through cutting-edge science and model-informed drug development (MIDD).
Company Snapshot
- Privately held biotech with a strong pipeline in oncology
- Founded by industry veterans with a track record of success
- Collaborative, mission-driven culture with a focus on scientific excellence
- Based in the San Francisco Bay Area with flexible work arrangements
Position Summary
The Executive Director will lead the strategic and operational aspects of clinical pharmacology, pharmacokinetics, and pharmacometric modeling across the company's development programs. This individual will serve as a key scientific leader, working cross-functionally and managing external partnerships to ensure robust data interpretation and regulatory readiness.
Key Responsibilities
- Provide strategic oversight of clinical pharmacology and pharmacometric activities
- Contribute to clinical development plans and study designs with a focus on MIDD
- Lead modeling and simulation efforts to support dose selection and regulatory submissions
- Manage relationships with CROs and external modeling partners
- Interpret and communicate emerging PK/PD and exposure-response data
- Ensure compliance with GCP and regulatory standards
Ideal Candidate Profile
- PhD or equivalent in Clinical Pharmacology, Pharmacokinetics, or a related field
- Extensive industry experience in drug development, ideally in oncology
- Proven leadership in clinical pharmacology and pharmacometric modeling
- Proficiency with tools such as WINNONLIN, R, NonMem, SAS, SIMCYP
- Strong communication and cross-functional collaboration skills
- Experience supporting NDA submissions is highly desirable
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