VP of Drug Development

Job Description

This position is responsible for all preclinical and clinical development work for protein therapeutic projects at the company. Capabilities and responsibilities must span preclinical safety pharmacology, pharmacokinetic and toxicological studies in animals as well as animal models for efficacy, along with clinical evaluations of safety, clinical pharmacology, pharmacokinetics and efficacy in human volunteers and patients.
Assume primary medical responsibility at the company for clinical trials.
Design preclinical and clinical development strategies for the company’s protein projects and provide strategic and operational development input for partnered and co-developed protein projects.
Generate extramural budget proposals for all development studies and track costs to budget.
Work through CROs to design, power and carry out preclinical and clinical studies.
Work in partnership with the head of Regulatory to plan and carry out meetings with Regulatory Authorities, where the incumbent will represent and defend activities in the preclinical and clinical development areas.
The position may involve one or more direct reports in the areas of clinical trial management. The incumbent must be effective in networking with other departments within the individual project teams to collect required inputs for development tasks.
M.D. and 10 years aggregate experience designing and executing preclinical and clinical development programs for pharmaceuticals (large or small molecular entities) in a corporate setting; budget management and personnel supervisory experience; experience in activities related to regulatory affairs and project management; strong communication and organizational skills. At least a portion of development experience must have been with therapeutic recombinant biologicals for human use.
Extensive experience with biologicals, particularly infectious disease, inflammation, cardiovascular, oncology and hematology is advisable.