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Associate Director/Director, Clinical Pharmacology

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Summary:

We are seeking a resourceful and motivated Associate Director/Director of Clinical Pharmacology reporting to the VP of Clinical Pharmacology, to support an expanding portfolio of ADC therapeutics. This role is primarily responsible for developing, driving, and implementing Clinical Pharmacology and Pharmacometric strategies for Antibody Drug Conjugates (ADC), and may also support DMPK activities. As a core member of the cross-functional development team, the successful candidate will collaborate closely with colleagues in research, toxicology, clinical development, clinical operations, biometrics, regulatory affairs, and project management. The successful candidate will contribute to IND submissions, clinical development programs, late-stage development activities, and interactions with health authorities. This position is primarily remote but requires strong collaboration with teams based in the San Francisco Bay Area. Some travel to the Burlingame, CA office will be required.

Key responsibilities:

• Serve as the Clinical Pharmacology lead on ADC development teams and provide PK/PD expertise.
• Lead the analysis, interpretation, integration, and reporting of clinical pharmacokinetic and pharmacodynamic data to inform development decisions.
• Apply quantitative methodologies—including population PK/PD, exposure–response modeling, and PBPK—to support dose and schedule selection, clinical trial design, special population strategies, and regulatory submissions.
• Author or provide technical input for Clinical Pharmacology sections of regulatory documents (e.g., protocols, IBs, briefing packages, BLAs) and respond to health authority queries.
• Partner with and oversee consultants and CROs to execute clinical pharmacology activities and supplement internal expertise.
• Support nonclinical DMPK activities as needed, including oversight of CROs conducting in vitro and in vivo studies.
• Collaborate with Research, Bioanalytical, Clinical, Regulatory, Program Management, and other R&D stakeholders to ensure alignment and integration of Clinical Pharmacology strategies.

Skills & Experiences:

• Clinical Pharmacology experience with both large and small molecules required; ADC therapeutics experience preferred.
• Expertise in Clinical Pharmacology, PK/PD principles, ADME concepts, and quantitative modeling and simulation, with experience in study design, data analysis, and interpretation.
• Proficiency with pharmacokinetic and pharmacometric methodologies and software (e.g., NONMEM, WinNonlin).
• Well informed of current and emerging regulatory expectations for clinical pharmacology.
• Strong interpersonal skills with the ability to influence and collaborate effectively across cross-functional teams.
• Excellent verbal and written communication skills, with the ability to clearly articulate complex scientific concepts.
• A critical thinker and enthusiastic team player who thrives in dynamic, fast-paced environments.

Education & Experience

• Ph.D. or Pharm.D. in Pharmacokinetics or related field.
• Assoc Dir: a minimum of 5 years of relevant industry experience in Clinical and Quantitative Pharmacology.
• Director: a minimum of 8 years of relevant industry experience in Clinical and Quantitative Pharmacology.

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