Senior Director, Clinical Development
Insmed Incorporated
August 13, 2026
Remote
United States
Clinical Research and Development
Senior Director, Clinical Development
Responsibilities
- Provide clinical evaluation of potential in-licensing or acquisition opportunities coordinated by Business Development.
- Contribute clinical input into Due Diligence teams for external molecules.
- Provide clinical input to cross-functional planning for molecules at the Late Lead Optimization stage.
- Serve on transition teams for in-licensed, acquired, or partnered molecules.
- Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care.
- Partner with Global Clinical Development to monitor benefit–risk profiles, manage safety signals, and support regulatory communications/meetings.
- Collaborate on design of clinical studies and Clinical Development Plans (CDPs) meeting ICH-GCP, ethical, and regulatory standards.
- Build and maintain partnerships with external medical experts.
Qualifications
- MD, MD/PhD, or equivalent medical training required.
- Board certification in internal medicine specialty including immunological disorders (e.g., Rheumatology or Transplantation).
- 7+ years clinical development experience in biotech/pharma.
- Meaningful drug development across modalities (oral small molecules and biologics); combination drug–device preferred.
- Phase 1–2a program leadership; combination drug–device and later-stage experience a plus.
- Strong regulatory knowledge (FDA, EMA, PMDA).
- Experience with oral small molecules/biologics; Original NDA/MAA/J-NDA experience is a plus.
Skills
- Strategic thinking and clinical judgment; high analytical rigor.
- Lead/influence in cross-functional matrixed organizations.
- Excellent written/verbal communication; external stakeholder engagement.
- Navigate ambiguity and make timely, balanced decisions.
Work/Travel/Pay
- Fully remote; occasional domestic/international travel (~10%).
- Pay range: $273,000–$372,000 annually.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities
- Provide clinical evaluation of potential in-licensing or acquisition opportunities coordinated by Business Development.
- Contribute clinical input into Due Diligence teams for external molecules.
- Provide clinical input to cross-functional planning for molecules at the Late Lead Optimization stage.
- Serve on transition teams for in-licensed, acquired, or partnered molecules.
- Maintain awareness of emerging science, competitive landscapes, and evolving global standards of care.
- Partner with Global Clinical Development to monitor benefit–risk profiles, manage safety signals, and support regulatory communications/meetings.
- Collaborate on design of clinical studies and Clinical Development Plans (CDPs) meeting ICH-GCP, ethical, and regulatory standards.
- Build and maintain partnerships with external medical experts.
Qualifications
- MD, MD/PhD, or equivalent medical training required.
- Board certification in internal medicine specialty including immunological disorders (e.g., Rheumatology or Transplantation).
- 7+ years clinical development experience in biotech/pharma.
- Meaningful drug development across modalities (oral small molecules and biologics); combination drug–device preferred.
- Phase 1–2a program leadership; combination drug–device and later-stage experience a plus.
- Strong regulatory knowledge (FDA, EMA, PMDA).
- Experience with oral small molecules/biologics; Original NDA/MAA/J-NDA experience is a plus.
Skills
- Strategic thinking and clinical judgment; high analytical rigor.
- Lead/influence in cross-functional matrixed organizations.
- Excellent written/verbal communication; external stakeholder engagement.
- Navigate ambiguity and make timely, balanced decisions.
Work/Travel/Pay
- Fully remote; occasional domestic/international travel (~10%).
- Pay range: $273,000–$372,000 annually.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.