Beyond A Resume
Beyond A Resume seeks a VP, Clinical Research for our biotech client in Hanover, MD.
The VP, Clinical Research reports to the Chief Development Officer, and is part of the Product Development Group which is responsible for all the strategic and clinical development of all products/programs.
-Leads all clinical and preclinical activities related to the clinical development programs, ensuring that the vision and direction of the project teams meet the mission and goals of the company, the quality of the research is at the standards required by the company and FDA, and that timelines are achieved
-Provides leadership in defining the strategy for products in development (e.g., pipeline products including design, conduct and management of clinical (Phase 1-4)
-Develops and reviews FDA documents (e.g., briefing documents, IND, NDA) and study related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.)
-Provides clinical regulatory science research expertise, especially regarding study design and data interpretation
-As additional staff are hired, directs staff to ensure efficiency for day-to-day operations and to meet the goals of the program
-Collaborates with members of other groups in the company (e.g., Project Management, Clinical Operations, Finance & Accounting) to achieve corporate goals
-Presents information and responds to questions from project teams, external vendors, KOLs, and customers.
-Proven ability to provide solutions to a variety of technical problems of moderate scope and difficult complexity.
-Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, KOLs, and customers
-M.D. degree with 8+ years’ experience with clinical development of oncology products.
-Oncology experience a must
-Experience leading clinical development teams and/or program building.
*Relocation assistance available to qualified candidate
*Remote capability available to qualified candidate
Job Type: Full-time
Salary: $300,000.00 – $350,000.00 per year
To apply for this job email your details to email@example.com