AD Clinical Pharmacology - GQR

Position: Associate Director, Clinical Pharmacology

Location: South San Francisco (Hybrid, 3 days onsite)

About the Role

Our client, a late-stage biopharmaceutical company, is seeking an Associate Director of Clinical Pharmacology to play a critical role in advancing innovative therapies for fibrotic diseases and oncology. This individual will lead the design, execution, and strategic oversight of clinical pharmacology plans, supporting both a late-stage fibrosis program and an early-stage oncology program.

This is a hybrid position based in South San Francisco, requiring three days onsite each week.

Key Responsibilities

• Act as Study Director for Phase 1 studies, ensuring high-quality and timely execution.
• Develop clinical pharmacology plans and contribute to regulatory submissions (e.g., INDs, NDAs).
• Collaborate with cross-functional teams and oversee modeling and simulation activities at CROs.
• Author and review clinical and regulatory documents, including protocols, statistical analysis plans, and study reports.
• Serve as the subject matter expert for clinical pharmacology during regulatory meetings.
• Ensure compliance with GCP and global regulatory guidelines.

Qualifications

• PhD in Pharmaceutics, Pharmacology, or related discipline.
• 6+ years of industry experience in clinical pharmacology, with a focus on small molecules.
• Hands on experience with PK/PD modeling
• Regulatory filing processes.

Compensation

The annual base salary for this role is $205,000–$215,000, plus performance-based bonuses. Additional equity and benefits will be provided.

Note: Our client is not offering visa sponsorship or transfer at this time.

If you're looking for a role where you can shape clinical pharmacology strategies and contribute to cutting-edge therapeutic programs, apply today!