Overview
The Director of Clinical Pharmacology will play a key role in shaping and executing clinical pharmacology strategies across early and late-stage development. This leader will design, analyze, and interpret PK and PK/PD studies, oversee Phase 1 CRO partnerships, and ensure translational alignment from preclinical characterization to patient dosing strategies. The position will also guide dose/regimen selection for pivotal studies, contribute to regulatory submissions, and present data to internal and external stakeholders. In addition, the Director may supervise pharmacometric analyses, mentor junior team members, and provide expert input into strategic evaluations and collaborations.

Key Responsibilities

• Serve as the Clinical Pharmacology lead for development programs, providing strategic input across discovery through registrational studies.

• Design and oversee early clinical studies (including first-in-human) and integrate PK/PD learnings into clinical development plans.

• Conduct or manage analyses such as non-compartmental PK evaluation, population PK, and PK/PD modeling and simulation.

• Draft and review clinical protocols, reports, and regulatory documents, ensuring high-quality, submission-ready deliverables.

• Partner with CROs to ensure operational excellence in early development studies.

• Contribute to dose selection and justification strategies for Phase 1 through Phase 3 programs.

• Collaborate cross-functionally with preclinical, biostatistics, medical, regulatory, and operations colleagues to deliver on development milestones.

• Represent the Clinical Pharmacology function on governance committees and study teams.

• Provide mentorship to junior staff and serve as a scientific resource within the organization.

Qualifications

• Advanced degree (PharmD or PhD) in Pharmaceutical Sciences, Pharmacology, or a related field.

• 7+ years of experience in clinical pharmacology and drug development, with expertise in PK, PD, and Pharmacometrics.

• Demonstrated leadership of clinical pharmacology strategies across multiple phases of development.

• Direct experience in Oncology drug development required; background in Radiopharmaceuticals strongly preferred.

• Proficiency with modeling tools such as NONMEM, R, or similar software.

• Strong knowledge of clinical trial methodology and regulatory expectations for global filings.

• Excellent communication skills, with the ability to work effectively in a cross-functional, matrixed environment.

• Track record of mentoring and developing scientific talent.