Note: The job is a remote job and is open to candidates in USA. Insmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking a Senior Director, Clinical Development to provide clinical leadership and support cross-functional discussions regarding potential in-licensing or acquisition opportunities, as well as contribute to the evaluation of molecules in immunological disorders.
Responsibilities
- 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
- Partner with Global Clinical Development functions to monitor benefit–risk profiles, manage safety signals, and support regulatory communications or meetings for any ongoing studies associated with in-licensed or acquired assets that are in transition to early GPT or GPT formation
- Collaborate with Global Clinical Development functions to support the design of potential clinical studies and Clinical Development Plans (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 that are in transition to early GPT or GPT formation, as well as emerging programs from Insmed discovery platforms
Skills
- MD, MD/PhD, or equivalent medical training is required
- Board certification in an internal medicine specialty that includes immunological disorders such as Rheumatology or Transplantation
- 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
- Demonstrated leadership in the design, execution, and interpretation of global Phase 1–2a clinical 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
- Strategic thinking and sound clinical judgment
- High scientific and analytical rigor
- 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
- Experience with combination drug–device products preferred
- Original NDA, MAA, and J-NDA experience is a plus
- Experience with combination drug–device development and later-stage programs is a plus
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- 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
- Meaningful opportunities to connect, volunteer, and give back
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