Description
An exciting and well funded biotechnology company is urgently seeking a Senior Medical Director/ Vice President of Clinical Development with a proven track record and expertise in Metabolics, Genetics and/ or endocrinology.Responsibilities:
- Designs, implements and monitors clinical studies of compounds designated for clinical development.
- Develops protocols and case report forms, which will provide adequate efficacy and safety information for Phases 1 to 4 of clinical trials.
- Interacts with data management personnel to plan data entry and analysis; recruits/screens/selects competent investigators; organizes investigators' meetings; assures that Good Clinical Practices (GCPs) are followed; assures timely completion of studies; monitors data for safety and efficacy trends by reviewing clinical data; and writes clinical reports upon completion or termination of studies (in cooperation with statistical staff).
- Reviews requests for results of Investigational New Drugs (IND) studies, and provides input for pharmacokinetics and pre-clinical studies.
- Prepares clinical portions of INDs, New Drug Applications (NDAs) and Biological License Applications (BLAs), including protocols, investigator brochures, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratios.
- Plans clinical programs and develops a timetable, budget and resource analysis for clinical programs and personnel administration.
- Establishes and maintains relationships with alliance partners, external companies, investigators and opinion leaders to optimize performance on clinical trial activities.
- Prepares manuscripts for technical journals and makes presentations at scientific meetings.
Education/Experience:
- Senior Medical Director position requires a MD with experience in a relevant scientific discipline (Metabolism, Genetics or Endocrinology) and a minimum of 5 years' experience in biotech/pharmaceutical.
- VP position requires a MD with experience in a relevant scientific discipline (Metabolism, Genetics or Endocrinology) and a minimum of 10 years' experience in biotech/pharmaceutical.
- Appropriate expertise will be considered in lieu of years of experience.