Senior Director, Clinical Development

Role Summary

Senior Director, Clinical Development at Insmed. Leads clinical strategy and development activities for mid-to-late-stage programs, focusing on the pulmonary arterial hypertension indication within TPIP. Responsible for clinical input into program strategy, regulatory engagements, and collaboration with cross-functional teams to ensure integrated global plans.

Responsibilities

• Leads clinical development team responsible for mid-to-late-stage development of TPIP in the PAH indication.
• Leads the matrix Clinical Study Team (CST) to effectively make decisions and handle conflict and change.
• Maintains a high degree of CST effectiveness through collaboration, influence, and coaching of cross-functional team members.
• Collaborates with the Clinical Program Lead to represent the matrix Global Asset Team and ensure the clinical program is integrated into Global plans across functions.
• Collaborates with the CPL to build strategic and coordinated clinical development plans aligned with business objectives and differentiated from competitors.
• Responsible for all clinical aspects of the clinical indication strategy.
• Accountable for the delivery of projects, partnering with other global development and related functions.

Qualifications

• MD/DO-equivalent with preference for Cardiology or Pulmonary formal training; industry experience in Pulmonary or Cardiology in drug development considered.
• 6+ years in biotech or pharma with most in a global clinical development role, or equivalent research experience; combination of drug/device experience is a plus.
• sNDA or sBLA experience or original NDA or BLA experience preferred; J-NDA experience a plus.
• Experience with FDA advisory committees, CHMP Scientific Advisory Group, or CHMP Oral Explanation preferred.
• Previous direct people management required.
• Experience working in matrix development teams (e.g., Global Study Teams) required.

Skills

• Clinical development leadership
• Cross-functional collaboration and matrix team governance
• Regulatory strategy and engagement with health authorities
• Strategic planning and program management
• Communication of clinical goals and scientific rationale

Education

• MD/DO-equivalent; advanced training in Cardiology or Pulmonary preferred