Associate Director, Clinical Pharmacology - 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:

• PhD in Pharmaceutics, Pharmacokinetics, Pharmacology, or a related field, with 5+ years of relevant experience in the biotech/pharmaceutical industry.
• Strong clinical pharmacology background, particularly with small molecules.
• In-depth knowledge of population PK, PK/PD, and PBPK modeling techniques, along with expertise in data analysis and interpretation. Proven track record of applying these methods to advance clinical development programs.
• Hands-on experience with modeling and simulation is highly preferred.
• This position offers an exciting opportunity to play a pivotal role in the advancement of cutting-edge therapies in a fast-paced, dynamic environment.

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