Vice President, Clinical Development

Job Description

Lead the clinical development programs, strategically planning and executing clinical trials. Evaluate and refine development strategies to mitigate risks and expedite asset advancement. Direct the planning, delivery, and leadership of clinical trials from early to late phases. Develop and refine clinical trial protocols, ensuring scientific rigor, ethical considerations, and compliance with regulatory guidelines. Assume medical and clinical accountability throughout the clinical trial lifecycle, including safety monitoring, data interpretation, and risk management. Oversee biometrics and medical writing, ensuring studies are designed, analyzed, and summarized appropriately. Collaborate with the VP of Regulatory Affairs in developing and executing regulatory strategies for successful clinical trial approvals and submissions. Direct data analysis and reporting activities, providing strategic insights to support decision-making and regulatory submissions.

Qualifications

1. Bachelor’s Degree required. 2. Advanced degree preferred. 3. Minimum of 10 years of clinical development experience within the biotechnology or pharmaceutical industry, with at least 5 years’ experience leading teams in drug development and regulatory submission. 4. Experience overseeing multiple programs or studies. 5. Understanding of end-to-end management of clinical trial conduct, drug development, and clinical trials operations. 6. Understanding of global regulatory requirements and track record of navigating clinical trials to approval. 7. Excellent business acumen and ability to engage, lead, and align teams. 8. Outstanding written and verbal communication skills. 9. Willingness to work hands-on in a detail-driven, fast-paced, entrepreneurial environment. 10. Strategic agility with critical and logical thinking and ability to analyze problems. 11. Ability to establish and maintain collaborative working relationships.

Benefits

- Employer-sponsored insurance plans including medical, dental, and vision coverage. - Generous paid time off. - Retirement plan options. - Additional wellness and professional development programs.