Vice President, Clinical Development

📋 Description

• Manage clinical development programs, including strategic planning and execution of clinical trials.

• Assess and enhance development strategies to reduce risks and accelerate the progress of assets.

• Lead the planning, execution, and oversight of clinical trials from early to late phases.

• Spearhead the creation and refinement of clinical trial protocols, ensuring scientific integrity, ethical standards, and compliance with regulatory requirements.

• Take on medical and clinical responsibility throughout the clinical trial lifecycle, encompassing safety monitoring, data interpretation, and risk management.

• Supervise biometrics and medical writing to guarantee that all clinical and nonclinical studies are designed, analyzed, and summarized properly in line with timelines, quality practices, and relevant regulations.

• Partner with the Vice President of Regulatory Affairs to develop and implement regulatory strategies that facilitate successful clinical trial approvals and submissions.

• Oversee data analysis and reporting activities, providing strategic insights to aid decision-making and regulatory submissions.

⛳️ Requirements

• A Bachelor’s Degree is required.

• An advanced degree is preferred.

• At least 10 years of clinical development experience in the biotechnology or pharmaceutical sector, with a minimum of 5 years in team leadership roles guiding drug candidates through early-to-late development and regulatory submission.

• Experience in overseeing multiple complex programs or studies.

• Comprehensive understanding of the complete management of clinical trial conduct, clinical drug development, and clinical trials operations.

• Profound knowledge of global regulatory requirements and a proven track record in successfully navigating clinical trials to approval.

• Strong business acumen with a demonstrated capacity to engage, lead, and align teams to fulfill business and program goals.

• Exceptional written and verbal communication skills, including the ability to convey complex ideas clearly.

• Willingness and capability to work hands-on in a detail-oriented, fast-paced, entrepreneurial setting.

• Strategic agility with robust critical and logical thinking skills, along with the ability to analyze problems effectively.

• Capacity to establish and maintain collaborative working relationships with both 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.