Position Summary:
Associate Director, Clinical Pharmacology responsible for design, leadership, and implementation of clinical pharmacology strategies across clinical programs; communicates strategy to senior management, regulatory agencies, and external peers; interprets data and implications; liaison to other departments.
Responsibilities:
- Lead clinical pharmacology strategy integrating PK, PD, and drug-drug interaction assessments across clinical trials.
- Provide independent clinical pharmacology support/guidance to clinical stage project teams.
- Develop/oversee clinical pharmacology study design (e.g., dose escalation, PK/PD modeling) for early candidates; support dosing strategy and evidence generation.
- Provide input for regulatory submissions (briefing documents, IND, CTA, NDA) and review protocols/reports for regulatory filings.
- Author/input clinical protocol sections and documents (e.g., Investigator Brochures, Clinical Study Reports) for clinical pharmacology.
- Partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
Qualifications/Requirements:
- Ph.D. (or equivalent); 4+ years experience, or PharmD with 8+ years.
- Knowledge across multiple therapeutic/functional areas; experience across development phases.
- Leadership in PK/PD, biopharmaceutics, pharmacometrics; scientific/project leadership; project management.
- Clinical pharmacology/therapeutic knowledge in one or more disease areas; experience with MIDD strategies.
Additional Skills/Requirements:
- Strong leadership, communication, collaboration, multitasking, and ability to present complex data.
- Travel ~10%; onsite presence in San Diego required (not 100% remote).
Benefits/Compensation:
- Premium health, work-life/well-being, wellness/support, life insurance, disability, retirement match, generous paid time off.
- Target base pay range: $150,000β$195,000.
Application Instructions:
- Applications accepted on an ongoing basis until a candidate is selected.