Senior Director, Head of Clinical Pharmacology - Oncology

San Francisco, California (Hybrid)

Salary: 290-330,000 base + 30% bonus + RSUs + additional benefits

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 to provide scientific, strategic, and operational leadership across its development portfolio.

This is a highly visible leadership position for a seasoned clinical pharmacology expert who enjoys remaining hands-on with the science while leading a growing function. The successful candidate will play a pivotal role in guiding clinical pharmacology, translational PK/PD, modeling and simulation strategies from early development through registration, partnering closely with executive leadership and cross-functional stakeholders to accelerate development decisions and optimize patient outcomes.

This role reports into senior development leadership and will oversee a team that includes two Associate Director-level Clinical Pharmacology professionals and an external consultant.

Key Responsibilities

Clinical Pharmacology Leadership

• 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.

Modeling & Simulation

• 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.

Regulatory & Development Strategy

• 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.

Cross-Functional Collaboration

• 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.

Team & Vendor Management

• 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
  • People management
• 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.