Project Manager, THRIVE PERC Program

Responsibilities

• Project Management & Coordination
  • In addition to the PERC Program Director, serve as the primary point of contact between the PERC team and the ARPA-H THRIVE Program Manager, Contracts Officer, and associated government personnel.
  • Maintain and manage the integrated program Gantt charge across all modules (Mod. 1 nonclinical D&D, Mod. 2 investigational medicine, Mod. 3 pilot and scale), ensuring cross-workstream dependencies are tracked and risks are surfaced early.
  • Convene and facilitate regular internal team meetings across Broad, clinical sites, CDMOs, and patient organization partners; prepare agendas, drive decisions, and track action items to closure.
  • Cook up and manage all ARPA-H required reporting, including monthly technical and financial status reports, quarterly reviews, and end-of-module reports; ensure submissions are on time, accurate, and tell a coherent narrative of progress.
  • Milestone & Budget Oversight
    • Track progress against THRIVE’s defined milestones, metrics, and point system across all modules, and flagging payment risks in advance.
    • Provide monthly financial reports and other requested materials to ARPA-H contract and program officers as requested.
    • Partner with sponsored research teams at the Broad and PERC partner institutions to manage the program budget, monitor burn rate against the milestone payment schedule, and support cost-share tracking.
    • Coordinate vendor and CDMO deliverables and nonclinical study timelines against the critical path to IND.
• Regulatory & Compliance Coordination
  • Support regulatory strategy efforts in coordinating regulatory submissions and meeting logistics, including INTERACT, pre-IND, IND, and any parallel FDA interactions.
  • Ensure that all regulatory correspondence and public disclosure deliverables are documented, tracked, and submitted within required timeframes based on receipt of regulatory feedback.
  • Cook up and manage IBC, IACUC, IRB, and any other assurance documentation across performing institutions, ensuring that all approvals are in place before relevant costs are incurred.
  • Support preparation for and attendance at THRIVE regulatory roundtables (twice yearly) and monthly regulatory affairs meetings with the ARPA-H team.
• Stakeholder & Partner Management
  • Serve as the operational liaison to clinical site partners for site activation, integration, patient consent and enrollment coordination, and any short/long-term follow up logistics.
  • Cook up and manage with patient advocacy partners on program engagement activities and community-facing communications.
  • Facilitate inter-team communication across internal PERC teams and external networks relevant to scaling and knowledge-sharing objectives.
• Risk Management & Strategic Execution
  • Maintain a living risk register across nonclinical, CMC, clinical, regulatory, IP, and other relevant workstreams; develop and track mitigation plans in collaboration with key workstream leads.
  • Proactively identify scope, timeline, and/or resource issues and escalate with proposed solutions.
  • Maintain program agility as fundamental nonclinical milestones are attempted and/achieved and as regulatory feedback evolves.

Qualifications

• Bachelor’s degree in life sciences, biomedical sciences, public health, or a related field; advanced degree (MS, MPH, PharmD, or PhD) strongly preferred.
• Minimum 5 years of experience in drug development program management.
• Direct experience in rare disease and/or gene therapy programs strongly preferred.
• Understands how nonclinical, CMC, clinical, and regulatory workstreams interact and can anticipate downstream impacts of upstream decisions.
• Demonstrated experience managing IND-enabling and/or clinical-stage programs in a multi-institutional or CRO/CDMO-partnered setting.
• Familiarity with FDA regulatory pathways for gene therapies and advanced biologics, including IND strategy, pre-IND interactions, and accelerated approval mechanism; experience with platform IND concepts a strong plus.
• Proficiency with program management tools such as Microsoft Project, Google Sheets, Smartsheets, etc and experience building and maintaining complex Gantt charts.
• Prowess with producing high-quality written deliverables including but not limited to progress reports, briefing materials, meeting summaries, etc for government, institutional, executive, and public audiences.
• Exceptional interpersonal and communication skills; demonstrated ability to manage across scientific, clinical, operational, and external stakeholder groups.

Preferred Experience

• Experience with federally funded research programs, particularly NIH, DARPA, and/or ARPA-H.
• Familiarity with AAV manufacturing and CMC development timelines, including CDMO management.
• Experience with CNS rare disease or pediatric rare disease programs.
• Familiarity with N-of-1 or adaptive clinical trial designs.
• Prior experience at an academic research institute, hospital, and/or drug development organization.

Key Competencies

• Able to drive progress in a novel, precedent-setting program where regulatory and scientific pathways will evolve.
• Communicates with confidence across scientists, clinicians, operational staff, regulatory strategists, ARPA-H program offices, patient families, and other key stakeholders.
• Takes ownership of timelines and deliverables and is proactive in managing and escalating risks and mitigations.
• Genuinely motivated by the prospect of helping deliver individualized genetic medicines to patients with currently untreatable conditions.

Pay Range

Pay Range: $83,000.00/yr - $116,333.00/yr