Sr. Dir to Exec. Director, Clinical Pharmacology (MD) - United States
This key position will serve as the clinical lead in the planning and conduct of Clinical Pharmacology studies, safety monitoring, and contributing to the finalization of reports for those studies (e.g. single and multiple ascending dose studies, drug-drug interaction studies in healthy volunteers, organ dysfunction studies etc.). The studies will be conducted at a CRO chosen by the Sponsor.
The position is required to work closely with scientists in Clinical Pharmacokinetics and Pharmacometrics, Drug Metabolism and Transporters, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and senior management as necessary.
- Protocol input and/or authoring
- Periodic communications with the CRO
- Frequent review of safety assessment conducted by the CRO
- Review and sign-off all paperwork
- M.D. (any specialty); licensure preferred
- Experience in conducting clinical trials is a must
- Any experience in conducting or monitoring healthy volunteer studies is highly desirable
- At least 5 years of experience in drug development, preferably at a clinical CRO or pharma is desirable
- Prior experience in pharmacovigilance, safety monitoring, safety reporting, interactions with FDA etc. will be valuable