Vice President, Clinical Development

Role Overview

• Oversee clinical development programs including strategic planning and execution of clinical trials
• Evaluate and refine development strategies to mitigate risks and expedite the advancement of assets
• Direct the planning, delivery and leadership of clinical trials from early to late phases
• Lead the development and refinement of 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 to ensure all clinical and nonclinical studies are designed, analyzed and summarized appropriately in accordance with timelines, good quality practices and applicable regulatory requirements
• Collaborate with the Vice President, Regulatory Affairs in the development and execution of regulatory strategies to facilitate successful clinical trial approvals and submissions
• Direct data analysis and reporting activities, providing strategic insights to support decision-making and regulatory submissions

Requirements

• Bachelor’s Degree required
• Advanced degree preferred
• Minimum 10 years of clinical development experience within the biotechnology or pharmaceutical industry, with at least 5 years’ experience leading teams in the progression of drug candidates through early-to-late development and regulatory submission
• Experience overseeing multiple, complex programs or studies
• Detailed understanding of end-to-end management of clinical trial conduct, clinical drug development and clinical trials operations
• Deep understanding of global regulatory requirements and successful track record of navigating clinical trials to approval
• Excellent business acumen and demonstrated ability to engage, lead and align teams to achieve business and program objectives
• Outstanding written and verbal communication skills, including the ability to use clear language to explain complex ideas
• Possess a willingness and ability to work hands-on in a detail-driven, fast-paced, entrepreneurial environment
• Strategic agility with strong critical and logical thinking and ability to analyze problems
• Ability to establish and maintain collaborative working relationships with internal and external stakeholders.

Benefits

• employer sponsored insurance plans including medical, dental and vision coverage;
• generous paid time off;
• retirement plan options;
• additional wellness and professional development programs