Senior Director, Clinical Research & Development

About the role

We're seeking a Senior Director, Clinical Research & Development to join our Clinical Development team. Reporting to the Vice President, Disease Area Head, Respiratory, you'll support two key activities: evaluating potential in-licensing or acquisition opportunities and assisting with cross-functional discussions for molecules advancing from Insmed's discovery platforms.

Responsibilities

• Provide clinical input into Due Diligence teams for external molecules.
• Contribute clinical input to cross-functional planning for molecules at the Late Lead Optimization stage.
• Serve on transition teams for in-licensed, acquired, or partnered molecules.
• Oversight of clinical execution and management of development planning and external engagement.
• Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care.

Requirements

• An MD, MD/PhD, PharmD or equivalent medical training with board certification in an internal medicine specialty preferred.
• At least 7 years of clinical development experience in biotech or pharmaceutical settings, with drug development experience across modalities including oral small molecules and biologics; experience with combination drug-device products preferred.
• Demonstrated leadership in designing, executing, and interpreting global Phase 1-2a clinical programs; experience with combination drug-device development and later-stage programs.
• Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• Proven ability to lead and influence effectively within cross-functional, matrixed organizations.
• Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.

Qualifications

• Original NDA, MAA, and J-NDA experience.
• Experience with original NDA, MAA, and J-NDA.

Skills

• Strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• Proven ability to lead and influence effectively within cross-functional, matrixed organizations.
• Excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP). Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration are also available. The 401(k) plan includes a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance. Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back are also provided.

Pay

$273,000.00 - $372,000.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected. Travel Requirements: Up to 20% domestic/international travel.