Senior Director, Head of Clinical Pharmacology - Oncology

About the opportunity

Our client, a clinical-stage biotechnology company advancing innovative therapies across oncology and immunology-focused programs, is seeking an accomplished Senior Director, Head of Clinical Pharmacology-Oncology.

Key Responsibilities

• Provide strategic leadership for Clinical Pharmacology and Translational PK/PD activities across multiple development programs.
• Serve as the clinical pharmacology subject matter expert on cross-functional project teams.
• Develop and implement fit-for-purpose clinical pharmacology strategies supporting programs from preclinical development through commercialization.
• Influence key development decisions related to dose selection, optimization, and benefit-risk assessment.
• Lead the application of PK/PD, Population PK (PopPK), exposure-response, and model-informed drug development approaches.
• Utilize quantitative methodologies to support dose justification, clinical study design, and regulatory interactions.
• Drive innovative approaches that improve clinical development efficiency and decision-making.
• Author and contribute to regulatory submissions and supporting documentation, including: INDs, Briefing books, Clinical protocols, Investigator Brochures, NDA/BLA components, Regulatory responses, and Health Authority interactions.
• Ensure alignment of clinical pharmacology deliverables with overall development strategy.
• Partner closely with: Clinical Development, Clinical Operations, Biometrics, Bioanalytical Sciences, Regulatory Affairs, Translational Medicine, CMC, Research & Discovery.
• Support integrated program planning and execution across the portfolio.
• Lead, mentor, and develop the Clinical Pharmacology function.
• Manage internal resources and external consultants/vendors to ensure high-quality execution.
• Establish departmental best practices, foster scientific excellence, and build organizational capabilities.
• Manage departmental budgets and resource allocation across multiple programs.

Qualifications

• Required: PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutics, or a related scientific discipline. 10+ years of pharmaceutical or biotechnology industry experience in Clinical Pharmacology, DMPK, or related functions.
• Deep expertise in: Clinical pharmacology, PK/PD modeling, Population PK, exposure-response analysis, translational drug development, Oncology / Biologics.
• Extensive experience supporting development programs from candidate selection through late-stage development and regulatory submission.
• Strong understanding of global regulatory expectations related to clinical pharmacology.
• Experience contributing to regulatory filings and health authority interactions.
• Demonstrated success leading and developing high-performing scientific teams.
• Preferred: Experience supporting biologics, monoclonal antibodies, bispecific antibodies, or other complex therapeutic modalities.
• Oncology drug development experience is required.
• Experience working in highly collaborative, fast-paced biotechnology environments.
• Strong scientific communication and executive stakeholder management skills.

Location & Work Environment

San Francisco, California
Hybrid schedule with approximately three days onsite per week
Flexibility regarding onsite days while maintaining a strong collaborative presence with the broader development organization.