Executive Director, Clinical Program Lead
Insmed Incorporated
August 20, 2026
Remote friendly (Bridgewater, NJ)
United States
Clinical Research and Development
About the Role:
Executive Director, Clinical Program Lead (CPL) providing clinical leadership for a respiratory asset across late Phase 2 and Phase 3b development. Core member of the Global Project Team (GPT), leading the Global Clinical Team overseeing physicians and clinical scientists for study design, execution, safety oversight, and regulatory engagement support.
What You’ll Do:
- Own and maintain the global Clinical Development Plan (CDP) aligned to the Target Product Profile (TPP) and portfolio strategy.
- Serve as clinical lead on the cross-functional GPT; accountable for clinical strategy and deliverables.
- Provide senior medical oversight of global studies, including benefit–risk assessment, safety signal management, and clinical input to regulatory interactions (FDA, EMA, PMDA).
- Lead design of mid-to-late-stage clinical trials in compliance with ICH-GCP, ethical standards, and global regulatory requirements.
- Build, lead, and develop a high-performing global clinical team.
- Establish and maintain strategic relationships with external experts, investigators, and advisors.
Who You Are:
- MD or MD/PhD and 10+ years of clinical development experience in biotech/pharma, with late-stage program leadership across small molecules and biologics.
- Leadership of global Phase 2–3b programs (strategy, execution, data interpretation).
- Strong knowledge of global regulatory pathways and interactions (FDA, EMA, PMDA).
- Ability to lead and influence in complex, matrixed organizations.
- Exceptional written/verbal communication with scientific, regulatory, and executive stakeholders.
- Strategic clinical judgment, scientific rigor, decisive action in ambiguity.
- Commitment to patient safety, data integrity, and ethical standards.
Nice to Have (Preferred):
- Board certification in Pulmonary or Allergy.
- Combination drug–device experience focusing on respiratory diseases.
Work/Travel/Pay:
- Hybrid role (Bridgewater, NJ); remote most of the time with in-person collaboration as needed.
- Occasional travel (~20%).
- Pay range: $306,000.00–417,000.00 annually.
Application:
- Current Insmed employees: apply via the Jobs Hub in Workday.
Executive Director, Clinical Program Lead (CPL) providing clinical leadership for a respiratory asset across late Phase 2 and Phase 3b development. Core member of the Global Project Team (GPT), leading the Global Clinical Team overseeing physicians and clinical scientists for study design, execution, safety oversight, and regulatory engagement support.
What You’ll Do:
- Own and maintain the global Clinical Development Plan (CDP) aligned to the Target Product Profile (TPP) and portfolio strategy.
- Serve as clinical lead on the cross-functional GPT; accountable for clinical strategy and deliverables.
- Provide senior medical oversight of global studies, including benefit–risk assessment, safety signal management, and clinical input to regulatory interactions (FDA, EMA, PMDA).
- Lead design of mid-to-late-stage clinical trials in compliance with ICH-GCP, ethical standards, and global regulatory requirements.
- Build, lead, and develop a high-performing global clinical team.
- Establish and maintain strategic relationships with external experts, investigators, and advisors.
Who You Are:
- MD or MD/PhD and 10+ years of clinical development experience in biotech/pharma, with late-stage program leadership across small molecules and biologics.
- Leadership of global Phase 2–3b programs (strategy, execution, data interpretation).
- Strong knowledge of global regulatory pathways and interactions (FDA, EMA, PMDA).
- Ability to lead and influence in complex, matrixed organizations.
- Exceptional written/verbal communication with scientific, regulatory, and executive stakeholders.
- Strategic clinical judgment, scientific rigor, decisive action in ambiguity.
- Commitment to patient safety, data integrity, and ethical standards.
Nice to Have (Preferred):
- Board certification in Pulmonary or Allergy.
- Combination drug–device experience focusing on respiratory diseases.
Work/Travel/Pay:
- Hybrid role (Bridgewater, NJ); remote most of the time with in-person collaboration as needed.
- Occasional travel (~20%).
- Pay range: $306,000.00–417,000.00 annually.
Application:
- Current Insmed employees: apply via the Jobs Hub in Workday.