VP, Clinical Development and Operations
1001 Winstead Dr, Ste 310 Cary, NC 27513 US
The Vice President, Clinical Development & Operations (CD&O) is responsible for providing leadership for the Clinical Development and the Clinical Operations teams across all of company development programs. Reporting to the CMO, the incumbent is a member of the Company’s R&D and Medical Affairs leadership teams as well as the Executive Management team. The incumbent provides strategic and tactical implementation leadership for all the Company’s assets entering into clinical development from Phase 1 through Phase 3 and also oversees post-approval clinical studies.
Candidates must either be based in the Cary, North Carolina area or be willing to relocate in the near future.
Summary Of Key Responsibilities
- Leads and manages the Clinical Research and Clinical Operations department ensuring that the vision and direction of the group 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 and budgets are achieved.
- Develops strategies and leads implementation of clinical outsourcing including selection of vendors, CROs, and other external resources needed to successfully operationalize clinical development.
- Provides clinical science research expertise, especially study design and data interpretation to achieve high quality protocol development and execution.
- Develops subject matter expertise in the therapeutic areas of interest to the Company and clearly communicates, both internally and externally, the science behind our products and pipeline.
- Leads interactions with external thought leaders and KOLs to help formulate clinical strategies and development plans to deliver the best possible outcomes for our product development.
- Manages all clinical operations activities, internal and external, on behalf of the Company ensuring high quality data generation in support of its commercial product and pipeline programs.
- Provides leadership experience to the running of clinical trials including identifying program risks and developing mitigation strategies to ensure clinical programs stay on time and within budget.
- Collaborates with members of other functions in the Company (e.g., Regulatory Affairs, Medical Affairs, Pharmaceutical Development, Sales/Marketing, et al.) to achieve corporate goals.
- Provides leadership in defining the development strategy for products in development (e.g., pipeline products, LCM programs, etc.), in designing studies and in the conduct and management of clinical studies.
- Develops, authors, and reviews regulatory documents (e.g., briefing documents, IND, NDA, etc.) and study-related documents (e.g., Investigator Brochure, CRFs, protocol, CSRs, etc.) and leads the clinical team in interactions with the FDA and other regulatory authorities.
- Works with the Company’s Business Development team and other colleagues to develop in-licensing strategies and provide key review and feedback on potential product candidates.
- Directs staff to ensure efficiency for day-to-day operations and to meet the goals of the program.
Required Qualifications And Skills
- Doctor of Medicine (MD) required.
- Minimum of 15 years’ industry experience, with a minimum of 12 years’ clinical operations and development experience required.
- Experience leading and coordinating the clinical drug development activities of at least one approved product.
- Experience leading cross-functional teams.
- Experience writing, reviewing, and editing regulatory and non-regulatory documents.
- Experience dealing with and solving a variety of development-stage clinical issues of broad scope and complexity.
Skills and Specifications:
- Strong management skills
- Excellent teamwork and collaboration skills
- Effective process and project management skills
- Solution oriented
- Outstanding written and verbal communication skills
- Expert knowledge of scientific principles and concepts
- Ability to multi-task
Travel Requirements: 30% (national and international)
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