Director, Clinical Pharmacology

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Are you ready to join a team committed to making a meaningful impact on therapeutic discoveries without compromising on a diverse and inclusive work culture? In our dynamic organization, we focus on driving precision medicine advancements while fostering a patient-centric mindset. Join us as we build a leading biotech organization, seeking passionate professionals to contribute to our transformative vision.

As a key player in our team, the Director of Clinical Pharmacology will play a vital role in developing and implementing nonclinical and clinical ADME strategies. This position involves collaborating across program teams to provide ADME perspectives, conduct modeling and analyses, and optimize development programs. The successful candidate will bring extensive experience in nonclinical and clinical ADME, demonstrating the ability to work cross-functionally to drive programs to success.

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.