VP, Program Team Lead

About the role

As Program Lead for MGX-001, you will drive the strategic vision for the lead clinical program from the planned Phase 1/2 trial through BLA filing. Reporting to the Chief Executive Officer, this hands‑on role leads the company’s first clinical program in a fast‑paced, public company environment, requiring strategic thinking and tactical execution. You will lead a cross‑functional team, develop integrated timelines and budgets, and serve as the primary point of accountability for the program’s progress to the executive team and Board.

Responsibilities

• Drive an integrated development strategy for MGX-001 from Phase 1/2 through BLA with cross‑functional input; clarify target product profile, clinical and regulatory path, and evidence package; continuously pressure‑test strategy against emerging data, competition, and regulatory expectations.
• Lead the MGX-001 core team, coordinating clinical development, regulatory, CMC development and GMP manufacturing, preclinical and translational sciences workstreams; chair core team meetings, drive decisions to closure, resolve competing priorities, and hold workstreams accountable to deliverables and timelines.
• Develop and maintain the detailed integrated program plan with clear critical path; work with finance to understand and manage the program budget; model timeline and resource scenarios to inform executive decisions and surface risks with mitigation options.
• Partner with medical and regulatory leads to execute regulatory strategy, including expedited pathway opportunities; own program readiness and content for Type B and Type C meetings, IND amendments, pre‑BLA interactions, BLA submission, and applications for orphan drug, RMAT and other FDA designations, plus comparable international meetings.
• Ensure quality and GXP compliance in all development phases; partner with CMC to plan GMP manufacturing and clinical drug product availability; anticipate needs for trial design and filing strategy.
• Lead and coordinate team updates on the MGX-001 program to the executive team and Board.

Qualifications

• Advanced degree required – PhD, PharmD, MD, or MS in a relevant life science discipline.
• 15 years of biopharmaceutical industry experience, including at least 5 years leading cross‑functional drug development teams or programs, ideally through a BLA/NDA submission.
• Demonstrated success leading a program across multiple phases of drug development and commercialization, with direct experience preparing and supporting US and international regulatory submissions (IND, CTA, BLA, MAA).
• Strong program management discipline with integrated timelines, critical path analysis, scenario planning, and budgeting, applied with judgment.
• Proven ability to lead through influence in a matrixed environment, including programs where functions such as regulatory or statistics are delivered by external partners.
• Working knowledge of GCP, GMP and CMC, and ICH guidelines sufficient to challenge internal teams and external partners, anticipate downstream issues, and keep quality and manufacturing aligned with the clinical plan.
• Experience in a publicly‑traded, small to mid‑sized biotech company is strongly preferred; comfort with public‑company demands including data disclosure and investor scrutiny.
• Direct experience in hemophilia and/or other rare bleeding disorders is a plus.
• Additional experience in gene therapy, gene editing, or another advanced therapy modality is preferred.
• Exceptional communication and leadership skills, with the ability to present complex clinical, regulatory, and manufacturing information clearly to both specialist and non‑specialist audiences, including the Board.

Benefits

• Eligible for an annual bonus.
• Company equity.
• Full range of benefits.

Pay

Anticipated base salary range: $285,000 to $400,000 (exempt position under the Federal Labor Standards Act).

Schedule

Full‑time, exempt position based in Emeryville, CA with hybrid flexibility. The role requires domestic and international travel; the specific travel schedule is determined collaboratively based on business needs.