Early Development Program Lead – Cambridge

About the Role

We’re looking for an Early Development Program Lead to help us expand what’s possible for patients with serious diseases. Reporting to the Chief Development Officer, the Early Development Program Lead will serve as the scientific and operational leader for one or more early-stage drug development programs emerging from the Cambridge Research team. This individual will be an experienced leader in the translational clinical science space. Serving as the critical bridge between discovery and development, they will drive cross-functional project teams as they evolve from late-stage lead optimization through IND, onboarding and engaging development functions to ensure scientific rigor, strategic alignment, and on-time delivery of program milestones.

What You'll Do

In this role, you’ll have the opportunity to serve as the primary bridge between the Cambridge Research organization and Insmed's Development functions; lead and coordinate cross-functional early development project teams spanning medicinal chemistry, CMC, formulation, biology, toxicology, DMPK/ADME, translational science, regulatory, clinical, and patient advocacy. You’ll also:

Project Leadership

• Provide strategic scientific project leadership and oversight for the cross-functional team to spearhead the definition of project objectives.
• Lead the definition and oversee execution of the scientific strategy for assigned small molecule and/or ASO programs, from late lead optimization up to IND.
• Establish productive working relationships with CROs and CDMOs to ensure timely completion of outsourced activities, partnering with relevant Insmed functions to identify, assess, and oversee.
• Integrate multi-disciplinary data to drive candidate selection decisions aligned with the Target Product Profile (TPP).
• Facilitate resource allocation and decision-making across functions with competing priorities and timelines.
• Set ambition and define & drive project strategy through key milestones; accountable for project timeline and execution to facilitate meeting deliverables necessary for project continuation.
• Lead identification and management of key risks across scientific, CMC, and clinical domains, including appropriate mitigation and contingency planning.

Project Management

• Work with Program Management to develop, maintain, and communicate integrated project plans, timelines, budgets, and risk registers.
• Lead cross functional discussions to develop early TPPs.
• Facilitate team meetings, drive decision-making, and ensure accountability across functions; prepare and present program updates to senior leadership and governance committees.
• Proactively identify and communicate risks and develop mitigation strategies to keep programs on track.
• Collaborate with portfolio management to ensure alignment with corporate strategy.
• Oversee provision of updates to the Cambridge Development Program team, to ensure timely awareness of approaching project needs and approaching development milestones.

Communication & Reporting

Author and review key program documents including early TPPs, project charters, integrated development plans, and support of any regulatory briefing documents; present program status and support presentations of scientific findings to internal leadership.

Who You Are

You must have a PhD in Medicinal Chemistry, Pharmacology, Pharmaceutical Sciences, Translational Medicine, Biochemistry, or a related discipline with direct relevance to small molecule or oligonucleotide drug discovery and development. Additionally, you have:

• 15+ years of experience in the pharmaceutical/biotech industry, with demonstration of increasing levels of responsibility.
• 5+ years of industry experience in small molecule drug and/or oligonucleotide therapeutic discovery and development.
• Demonstrated experience leading cross-functional drug development matrix teams in a pharmaceutical or biotech environment.
• A track record of advancing programs from lead optimization through IND and into FIH.
• Experience engaging with regulatory agencies (FDA, EMA) in early development settings (e.g., pre-IND meetings; INTERACT meetings) and Type B/C meetings.
• Highly effective and proactive communication skills with the ability to manage in a matrix environment by influence.
• Proficiency in building trust, inspiring confidence, clearly articulating challenges and opportunities, and bringing teams into alignment across complex decision making.