Early Development Program Lead – Cambridge
Insmed Incorporated
August 23, 2026
Remote
United States
Clinical Research and Development
Early Development Program Lead (Scientific & Operational Lead)
Responsibilities:
- Provide strategic scientific leadership and oversight to define project objectives.
- Lead scientific strategy execution for small molecule and/or ASO programs from late lead optimization through IND.
- Coordinate cross-functional early development teams (medicinal chemistry, CMC, formulation, biology, toxicology, DMPK/ADME, translational science, regulatory, clinical, patient advocacy).
- Partner with CROs/CDMOs to ensure timely outsourced activity completion.
- Integrate multi-disciplinary data to drive candidate selection aligned with Target Product Profile (TPP).
- Facilitate resource allocation and decision-making across functions.
- Define and drive project strategy via key milestones; ensure on-time delivery of milestones.
- Identify/manage key risks across scientific, CMC, and clinical domains with mitigation/contingency planning.
- Develop and communicate integrated project plans, timelines, budgets, and risk registers; support early TPP development.
- Author/review key documents (early TPPs, project charters, integrated development plans) and support regulatory briefing documents; present program status/findings to leadership.
Qualifications:
- PhD in Medicinal Chemistry, Pharmacology, Pharmaceutical Sciences, Translational Medicine, Biochemistry, or related discipline relevant to small molecule/oligonucleotide drug discovery/development.
- 15+ years pharma/biotech experience with increasing responsibility.
- 5+ years in small molecule and/or oligonucleotide therapeutic discovery and development.
- Experience leading cross-functional drug development matrix teams.
- Track record advancing programs from lead optimization through IND and into FIH.
- Regulatory engagement experience (FDA/EMA) in early development (e.g., pre-IND, INTERACT; Type B/C meetings).
- Highly effective proactive communication; ability to manage in a matrix environment by influence.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities:
- Provide strategic scientific leadership and oversight to define project objectives.
- Lead scientific strategy execution for small molecule and/or ASO programs from late lead optimization through IND.
- Coordinate cross-functional early development teams (medicinal chemistry, CMC, formulation, biology, toxicology, DMPK/ADME, translational science, regulatory, clinical, patient advocacy).
- Partner with CROs/CDMOs to ensure timely outsourced activity completion.
- Integrate multi-disciplinary data to drive candidate selection aligned with Target Product Profile (TPP).
- Facilitate resource allocation and decision-making across functions.
- Define and drive project strategy via key milestones; ensure on-time delivery of milestones.
- Identify/manage key risks across scientific, CMC, and clinical domains with mitigation/contingency planning.
- Develop and communicate integrated project plans, timelines, budgets, and risk registers; support early TPP development.
- Author/review key documents (early TPPs, project charters, integrated development plans) and support regulatory briefing documents; present program status/findings to leadership.
Qualifications:
- PhD in Medicinal Chemistry, Pharmacology, Pharmaceutical Sciences, Translational Medicine, Biochemistry, or related discipline relevant to small molecule/oligonucleotide drug discovery/development.
- 15+ years pharma/biotech experience with increasing responsibility.
- 5+ years in small molecule and/or oligonucleotide therapeutic discovery and development.
- Experience leading cross-functional drug development matrix teams.
- Track record advancing programs from lead optimization through IND and into FIH.
- Regulatory engagement experience (FDA/EMA) in early development (e.g., pre-IND, INTERACT; Type B/C meetings).
- Highly effective proactive communication; ability to manage in a matrix environment by influence.
Application instructions:
- Current Insmed employees: apply via the Jobs Hub in Workday.