At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.
Senior Director, Clinical Research & Development
Location
United States
Posted
37 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
We’re looking for a Senior Director, Clinical Research & Development on the Clinical Development team to help us expand what’s possible for patients with serious diseases. Reporting to the Vice President, Disease Area Head, Respiratory, you’ll serve as a clinical leader responsible for supporting two primary activities:
- Providing clinical evaluation of potential in-licensing or acquisition opportunities coordinated and led by Insmed’s Business Development organization.
- Supporting cross-functional discussions with Insmed discovery research platforms as molecules advance beyond the Late Lead Optimization milestone.
This is a remote role.
In this role, you’ll have the opportunity to provide clinical input into the overall assessment of external molecules as a member of Due Diligence teams. You’ll also:
- 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.
- Have oversight of clinical execution, along with management of clinical development planning and external engagement.
- Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care across relevant disease areas.
Qualifications
- 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.
- Meaningful drug development experience across modalities, including oral small molecules and biologics; experience with combination drug–device products preferred.
Requirements
- Original NDA, MAA, and J-NDA experience.
- 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.
- 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
- Comprehensive medical, dental, and vision coverage and 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.
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
- Company-paid life and disability insurance.
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.
Job Requirements
- 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.
- Meaningful drug development experience across modalities, including oral small molecules and biologics; experience with combination drug–device products preferred.
- Original NDA, MAA, and J-NDA experience.
- 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.
- 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
- Comprehensive medical, dental, and vision coverage and 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.
- 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
- Company-paid life and disability insurance.
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
- Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.
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