Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology will lead strategic direction and technical leadership within the Clinical Pharmacology function for early development. The role requires applying quantitative modeling and cross-functional collaboration to guide dose selection and study design, with a focus on small-molecule oncology assets in IND-enabling and early development phases.

Responsibilities

• Provide strategic insight and technical leadership within the Clinical Pharmacology function.
• Author technical reports and regulatory documents for major milestones (IND, EOP1, EOP2 Briefing Documents); participate in regulatory interactions and responses to regulatory questions.
• Apply quantitative modeling (translational PK/PD, population PK, exposure–response analyses) to guide RP2D selection for pivotal studies.
• Collaborate with Discovery to support IND-enabling assets, including DMPK and Toxicology input for human start dose and need for human DDI studies.
• Assist in designing First-in-Human studies with Clinical Development teams.
• Design and report Clinical Pharmacology studies (hADME, Food-Effect, DDI).
• Engage with CROs on clinical pharmacology activities.
• Represent Clinical Pharmacology in project teams and build cross-functional relationships to inform critical decisions.

Qualifications

• Required: Ph.D. or Pharm.D (with Fellowship) in Pharmaceutical Sciences with 8+ years of industry experience in Clinical Pharmacology.
• Required: Prior experience in small molecule oncology drug development.
• Required: Familiarity with FDA Project Optimus guidance.
• Required: Up-to-date knowledge of regulatory expectations for clinical pharmacology.
• Required: Hands-on experience with WinNonlin and Clinical Pharmacology study designs.
• Required: Strong understanding of DMPK, CMC, Toxicology and related regulatory guidance.
• Required: Excellent verbal and written communication skills; ability to convey complex concepts clearly to diverse audiences.
• Required: Critical thinker, collaborative team player with high energy in a fast-paced environment.
• Required: Prior management experience.

Preferred Skills

• Preferred: Experience interacting with FDA on dose optimization.
• Preferred: Hands-on experience with PBPK models.

Education

• Ph.D. or Pharm.D (with Fellowship) in Pharmaceutical Sciences (as listed in Qualifications).