Director, Clinical Pharmacology

Location United States of America
Discipline: Pharmacology
Job type: Permanent
Job ref: 987261
Published: 20 days ago
Expiry date: 30 Jun 2024 23:59

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.