Project Manager, THRIVE PERC Program

Pediatric Epilepsies & Rare CNS Gene Editing Platform Project Manager

The Pediatric Epilepsies & Rare CNS (PERC) Gene Editing Platform is the Center for Therapeutic Genetics (CTG) project funded by ARPA-H's THRIVE program. PERC aims to develop and clinically deploy platformized delivery of precision gene editors to treat children with developmental and epileptic encephalopathies (DEEs), including Alternating Hemiplegia of Childhood and Dravet syndrome. CTG at the Broad Institute serves as the coordinator hub for PERC, responsible for program leadership, regulatory strategy, centralized data management, IP stewardship, and other key administrative and operational tasks. The program spans IND-enabling nonclinical studies, CMC development with CDMO partners, clinical trial execution, and regulatory strategy targeting first-in-human dosing in less than 2 years. The ARPA-H THRIVE PERC Project Manager will own end-to-end operational coordination across a complex, multi-institutional team that includes the Broad Institute, the Jackson Laboratory, Boston Children's Hospital, Children's Hospital of Colorado, various patient advocacy organizations, and several biotech and industry partners. The PM will be responsible for ensuring program advancement on timeline against ARPA-H's defined objectives, metrics, and module payment milestones, and will serve as the operation backbone connecting nonclinical, CMC, clinical, and regulatory workstreams. This position reports to the PERC Program Director (Winston Yan, CTG Senior Director) and works in close coordination with the Center for Therapeutic Genetics Leadership and the PERC scientific and clinical teams. The role is based in Cambridge, MA, allowing for occasional remote work.

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.
• Coordinate data sharing, technology transfer, and communication protocols among all team members per THRIVE's Performer Agreement requirements.
• Organize 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.
• Coordinate 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.
• Coordinate 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 nonclincal milestones are attempted and/achieved and as regulatory feedback evolves.

QUALIFICATIONS

Required 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 Proven ability to produce 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 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.