Insmed Incorporated logo
Insmed Incorporated

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

Clinical ResearchClinical ResearchFull TimeRemoteTeam 1,001-5,000Company SiteLinkedIn

Location

United States

Posted

37 days ago

Salary

Not specified

No structured requirement data.

Job Description

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

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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