Senior Director, Clinical Pharmacology

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the Clinical Pharmacology lead for designated development programs from first-in-human studies through Phase 3 clinical trials.

• Create and implement program-specific clinical pharmacology strategies that align with overall development goals.

• Provide scientific direction for PK, PD, exposure-response, population PK, modeling, and simulation activities.

• Design and supervise clinical pharmacology studies, which includes protocol development, analysis plans, results interpretation, and reporting.

• Work in collaboration with cross-functional teams to incorporate clinical pharmacology into comprehensive development strategies.

• Collaborate with Clinical Development physicians, statisticians, pharmacometricians, Regulatory Affairs, Biometrics, and Medical Writing to facilitate program execution.

• Analyze clinical pharmacology data and convert findings into clear scientific and regulatory guidance.

• Aid in dose selection, dose optimization, labeling strategies, and benefit-risk evaluations.

• Assist in the preparation of regulatory submission documents, including INDs, briefing books, CTDs, clinical pharmacology summaries, and responses to inquiries from health authorities.

• Engage in regulatory agency meetings as a subject matter expert in clinical pharmacology.

• Oversee external CROs, consultants, and pharmacometric vendors supporting assigned programs.

• Keep abreast of new clinical pharmacology methodologies, regulatory requirements, and industry best practices.

• Contribute to scientific publications, presentations, and the sharing of internal knowledge.

• Mentor junior scientists and provide technical advice across project teams as necessary.

⛳️ Requirements

• PhD, PharmD, MD, or an equivalent advanced degree in Clinical Pharmacology, Pharmaceutical Sciences, Pharmacokinetics, Pharmacometrics, or a related scientific field.

• Approximately 10–15+ years of experience in the pharmaceutical or biotechnology industry, including substantial experience in clinical drug development support.

• At least 10 years of direct experience in Clinical Pharmacology.

• Experience in supporting various stages of clinical development, including early and late-stage projects.

• Proficient in preparing regulatory submissions and interacting with the FDA and other global health authorities.

• Experience with biologics, peptides, small molecules, or gene therapies is preferred.

• Strong comprehension of PK/PD principles and clinical pharmacology strategies.

• Experience with population PK and exposure-response evaluations.

• Familiarity with pharmacometric modeling and simulation techniques.

• Proficient in clinical pharmacology software such as NONMEM, Phoenix WinNonlin, R, SAS, or similar tools.

• Exceptional scientific writing and presentation abilities.

• Capability to independently interpret complex clinical data and communicate insights to senior leadership.

• Strong project management and organizational skills.

• Proven success in highly collaborative, cross-functional settings.

• Ability to manage multiple programs concurrently in a dynamic biotechnology environment.

• An entrepreneurial mindset with a readiness to contribute broadly across development initiatives.

🏝️ Benefits

• Remote work opportunities available within the United States.

• Travel to company-related events as required and requested.

• Equal Opportunity Employer.

• Accommodations provided for candidates needing assistance during the selection process.