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Associate Director, Clinical Pharmacology
1 month ago
- We are looking for an Associate Director, within our Clinical Pharmacology group.
- Providing strategic and scientific expertise, as well as representing Clinical Pharmacology at relevant meetings.
- Provide clinical pharmacology subject matter expertise to the Clinical Study Team/ Development Team.
- Draft, finalize, and/or review clinical pharmacology study reports and publications.
- Work closely with Regulatory to provide clinical pharmacology support of regulatory documents, communications and presentations as needed (IND, health authority inquires, preparation/participation in meetings with health authorities, preparation of BLA summary sections, addressing review inquiries, health authority sponsored Advisory Committee Meetings).
- Collaborate with Quantitative Pharmacology colleagues closely to develop and deliver agreed quantitative strategies to support assigned development plans.
- A PhD, Biology, Pharmacology, Engineering, Pharmacy (Pharm.
- D.), Medicine (MD) and at least 5 years of relevant Clinical Pharmacology experience.