Director, Clinical Pharmacology

​Essential Job Functions:

• Provide clinical pharmacology leadership on multi-disciplinary teams for programs in the therapeutic field.

• Offer clinical and nonclinical pharmacokinetic expertise, including study design, data analysis, and interpretation.

• Develop various models to evaluate risk/benefit and facilitate drug development decisions.

• Design and execute studies, such as drug-drug interaction studies, specific population assessments, BA/BE studies, and food effect studies.

• Provide support in the preparation of regulatory documents, including study protocols, CSRs, Investigator's Brochures, and sections of regulatory submissions.

• Participate in meetings with regulatory agencies and respond to regulatory queries.

Job Requirements:

• Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or a related discipline.

• 5+ years of experience for Associate Director or 8+ years for Director in clinical pharmacology, modeling & simulation, drug metabolism, and/or pharmacokinetics within pharma or biotech.

• Experience with nonclinical and clinical pharmacokinetic protocol design, including collaboration with CROs.

• Proficiency in Model Informed Drug Development.

• Strong organizational and time-management skills, with the ability to handle multiple projects simultaneously.

• Entrepreneurial spirit and a hands-on approach.

• Analytical and critical thinking skills with attention to detail.

• Creativity in problem-solving.

• Effective collaboration in cross-functional teams and with research partners.

• Excellent oral and written communication skills.