Director, Clinical Pharmacology
Location | United States of America |
Discipline: | Pharmacology |
Job type: | Permanent |
Job ref: | 987261 |
Published: | 3 months 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.
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