Senior Director, Clinical Research & Development

About the role

We're seeking a Senior Director, Clinical Research & Development for our Clinical Development team. Reporting to the Vice President, Disease Area Head, Respiratory, you'll support due diligence teams, contribute to cross-functional planning, and oversee clinical development planning.

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, as needed, 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.

Requirements

• You have an MD, MD/PhD, PharmD or equivalent medical training, with board certification in an internal medicine specialty preferred.
• You have 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.
• You have original NDA, MAA, and J-NDA experience.
• You have 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.
• You have a strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• You have proven ability to lead and influence effectively within cross-functional, matrixed organizations.
• You have excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.

Qualifications

• You have an MD, MD/PhD, PharmD or equivalent medical training, with board certification in an internal medicine specialty preferred.
• You have 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.
• You have original NDA, MAA, and J-NDA experience.
• You have 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.
• You have a strong understanding of global regulatory pathways and expectations, including FDA, EMA, and PMDA.
• You have proven ability to lead and influence effectively within cross-functional, matrixed organizations.
• You have excellent written and verbal communication skills, with the ability to engage scientific, regulatory, and executive stakeholders.

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.