Project Manager (Gene Therapy)

TL;DR

Project Manager (Gene Therapy): Coordinating end-to-end operational execution for a multi-institutional gene editing program with an accent on IND-enabling studies, CMC development, and regulatory strategy. Focus on managing complex cross-workstream dependencies, ensuring milestone compliance for ARPA-H, and facilitating communication across clinical, scientific, and industry partners.

Location: Must be based onsite in Cambridge, MA

Salary: $83,000–$116,333/yr

Company

A leading biomedical research institute dedicated to advancing human health through genomic medicine and collaborative scientific discovery.

What you will do

• Manage the integrated program Gantt chart across nonclinical, CMC, and clinical workstreams.
• Serve as the primary operational liaison between the internal team and ARPA-H program officers.
• Facilitate regular meetings across Broad, clinical sites, CDMOs, and patient advocacy partners.
• Oversee milestone tracking, budget burn rates, and financial reporting for government contracts.
• Coordinate regulatory submissions, including pre-IND and IND interactions with the FDA.
• Maintain a living risk register and develop mitigation plans for complex project dependencies.

Requirements

• Bachelor’s degree in life sciences or related field required; advanced degree preferred.
• Minimum 5 years of experience in drug development program management.
• Direct experience managing IND-enabling or clinical-stage programs in multi-institutional settings.
• Familiarity with FDA regulatory pathways for gene therapies and advanced biologics.
• Proficiency with program management tools like Microsoft Project or Smartsheets.
• Must be able to work onsite in Cambridge, MA.

Nice to have

• Experience with federally funded research programs like NIH, DARPA, or ARPA-H.
• Familiarity with AAV manufacturing and CDMO management.
• Experience with CNS or pediatric rare disease programs.
• Knowledge of N-of-1 or adaptive clinical trial designs.

Culture & Benefits

• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) retirement plan with employer contributions.
• Generous paid time off, 13 paid holidays, and winter closure.
• Support for parental and family care leave.
• Access to employee assistance programs and professional development resources.