Job Title: Director/Sr. Director, Clinical Development

Work Location: New York County, New York

Summary:

This leadership role is responsible for advancing late-stage clinical development programs, focusing on rare disease and gene therapy. The position requires strategic oversight, cross-functional collaboration, and hands-on leadership to ensure successful study execution and regulatory submission readiness. The Director/Sr. Director will play a key role in shaping clinical strategy, supporting regulatory interactions, and mentoring team members.

Responsibilities:

• Lead clinical development activities for late-stage Phase 2/3 and registrational studies, ensuring alignment with program objectives and regulatory requirements.
• Collaborate with cross-functional teams to develop and execute integrated clinical development plans, including regulatory, quality, biometrics, and medical writing functions.
• Oversee protocol development, endpoint selection, eligibility criteria, and safety monitoring to support health authority interactions and study success.
• Engage with investigators, external experts, and advisory boards to foster strong site relationships and support study enrollment and conduct.
• Drive resolution of cross-functional issues and manage risks to ensure study execution meets quality standards and inspection readiness.
• Contribute to regulatory submission readiness by coordinating clinical deliverables, timelines, and data review processes across functions.
• Mentor and lead team members through matrix leadership, promoting a culture of accountability, collaboration, and scientific excellence.
• Ensure effective communication and documentation of decisions, supporting audit and inspection readiness throughout the development lifecycle.

Qualifications:

• PhD, PharmD, or MD required.
• Minimum of 6 years of industry experience in clinical development (8 years for Senior Director level), with at least 5-6 years in late-stage trial delivery.
• Proven leadership in late-stage Phase 2/3 and registrational development for rare disease programs.
• Experience supporting regulatory submission readiness, including BLA filing activities and cross-functional coordination.
• Comprehensive knowledge of clinical development program management from IND through NDA/BLA, including audit and inspection readiness.
• Experience collaborating with Clinical Operations, CROs, and vendors to deliver high-quality data and documentation.
• Advanced understanding of ICH, GCP, and FDA guidelines and regulations.
• Strong communication skills and ability to influence across multiple functions and organizational levels.
• Ability to thrive in a fast-paced environment with shifting priorities and timelines.

Published Category: Clinical Operations & Development