What are the responsibilities and job description for the Associate Director, Clinical Pharmacology position at GQR?
Job Title : Associate Director, Clinical Pharmacology
Location : San Francisco Bay Area
Employment Type : Full-Time
Company Overview :
Clinical-stage biopharmaceutical company dedicated to the discovery and development of innovative therapies targeting oncology, central nervous system (CNS) disorders, and rare diseases.
Position Overview :
We are seeking an experienced Clinical Pharmacologist to lead the development of strategic, scientific, translational, and clinical aspects of clinical pharmacology plans across multiple indications. This role will involve overseeing all facets of clinical pharmacology for various drug development programs.
Key Responsibilities :
- Lead and manage Phase 1 clinical studies, including first-in-human trials, biopharmaceutics, drug-drug interactions, special populations, and proof-of-pharmacology / concept studies. Ensure the timely and high-quality execution of all clinical studies within the Pliant portfolio.
- Develop and author key clinical pharmacology sections of clinical and regulatory documents, including clinical protocols, study reports, statistical analysis plans, IND and IMPD submissions, regulatory briefing documents, pediatric investigational plans, and NDA / MAA submissions. Represent clinical pharmacology during regulatory interactions.
- Identify, develop, and manage external vendors for population pharmacokinetics (PK), PK / PD modeling, and physiologically-based pharmacokinetic (PBPK) modeling to support clinical development.
Qualifications :
