Vice President of Clinical Development
About the Position
The VP of Clinical Development will have full responsibility for directing the design and implementation of all clinical development programs of the company. A primary focus for this individual will be to oversee the clinical development of the company’s flagship Phase 3 program in lactose intolerance.
This position will design scientifically rigorous and maximally cost-effective clinical development plans and implement clinical R&D programs. Oversee and work closely with Preclinical, Regulatory, Clinical Operations, Biometrics, Medical Affairs and Commercial to ensure tight strategic integration of product development plans.
- Direct managerial oversight of clinical personnel (CRAs, CTM, etc…) and consultants, including CROs.
- Lead and manage clinical trial execution, including data analysis and reporting
- Work with regulatory to prepare documentation that are required for regulatory and legislative drug approvals (INDs, NDAs and other documents)
- Organize, plan, and present scientific information at investigator meetings and company advisory panels.
- Work closely with Key Opinion Leaders and Company’s medical advisory board
This is a full-time position located at the Company’s headquarters in Century City, Los Angeles, CA. No telecommute.
Skills & Knowledge Requirements
- Advanced degree (MD, PhD, or PharmD) highly desirable
- Eight or more years of industry related experience is desirable. Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience. Knowledge of clinical trial management, data management, and drug development process.
- Prior experience in clinical research design or implementation of protocols for Phase 2 and 3 programs.
- Therapeutic area experience in gastroenterology desirable but not essential
- Excellent oral and written communication skills, organizational skills, as well as interpersonal skills.
- Hard working, driven to achieve creative and sound results.
If interested, please email your CV to Shaun at email@example.com