Senior Director, Clinical Development

About the role

We're seeking a Senior Director, Clinical Development to join our Clinical Development team. This role involves clinical evaluation of potential in-licensing or acquisition opportunities and supporting molecules advancing from Insmed's discovery platforms.

Responsibilities

• Provide clinical input into the assessment of external molecules as a member of Due Diligence teams.
• Contribute clinical input to cross-functional planning for molecules emerging from Insmed discovery platforms at the Late Lead Optimization stage.
• Serve on transition teams for molecules that are in-licensed, acquired, or partnered.
• Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas.
• Partner with Global Clinical Development functions to monitor benefit-risk profiles, manage safety signals, and support regulatory communications or meetings for in-licensed or acquired assets.
• Collaborate with Global Clinical Development functions to support the design of potential clinical studies and CDPs that meet global ICH-GCP, ethical, and regulatory standards.
• Build and maintain strong partnerships with external medical experts supporting development programs for in-licensed or acquired assets and emerging programs from Insmed discovery platforms.

Requirements

• MD, MD/PhD, or equivalent medical training with board certification in an internal medicine specialty including immunological disorders such as Rheumatology or Transplantation.
• At least 7 years of clinical development experience in biotech or pharmaceutical settings, with meaningful drug development experience across modalities, including oral small molecules and biologics; experience with combination drug-device products preferred.
• Experience with original NDA, MAA, and J-NDA.

Qualifications

• Demonstrated leadership in the design, execution, and interpretation of global Phase 1-2a clinical programs.
• Experience with combination drug-device development and later-stage programs is a plus.
• 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.
• Strategic thinking and sound clinical judgment.
• Strong influence and decision-making skills in matrixed environments.
• Excellence in communication and external engagement.
• Ability to navigate ambiguity and make timely, balanced decisions.
• Effective collaboration across global, cross-functional teams.

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.
• Strategic thinking and sound clinical judgment.
• Strong influence and decision-making skills in matrixed environments.
• Excellence in communication and external engagement.
• Ability to navigate ambiguity and make timely, balanced decisions.
• Effective collaboration across global, cross-functional teams.

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 provided. 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 available.

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 are approximately 10%.