VP, Program Lead — Gene Therapy Development

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Full Time Emeryville, CA, US

30+ days ago Requisition ID: 1003

Salary Range: $285,000.00 To $400,000.00 Annually

Metagenomi Therapeutics is an in vivo genome editing company capitalizing on its proprietary technologies to create curative genetic medicines for patients. The Company was founded on the science of metagenomics, the study of genetic materials recovered from the natural environment, to discover and develop a suite of novel editing tools potentially capable of correcting any type of genetic mutation found anywhere in the human genome.

MGX-001 is our lead, wholly-owned development program in hemophilia A, which has demonstrated a preclinical profile potentially competitive with best-in-class treatment options, including targeted genome editing and durable gene expression in a one-time treatment. We are also currently pursuing other indications leveraging the MGX-001 site-specific genome integration system and partnered assets targeting cardiometabolic diseases.

The Role

As Program Lead for MGX-001, you will drive the strategic vision for our lead clinical program from the currently planned Phase 1/2 trial through BLA filing. You will be a key point of accountability for MGX-001, contributing significantly to the planned success of the program. Reporting to the Chief Executive Officer, this is a hands-on role leading the company’s first clinical program in a fast-paced, public company environment. This role requires a leader who is both a strategic thinker and a tactical executor. You will drive the program's development strategy and integrated timeline, lead a cross-functional team, and serve as the person the executive team and Board look to for an overall clear and current picture of where MGX-001 stands.

Based in Emeryville, CA, Metagenomi offers hybrid flexibility for this role. Domestic and international travel is required, with scheduling determined collaboratively based on business needs.

Metagenomi does not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement in place will be considered unsolicited, and Metagenomi will not be obligated to pay any placement fee.

Key Responsibilities

Program Strategy & Vision: Drive an integrated development strategy for MGX-001 from Phase 1/2 through BLA with cross-functional input. Clarify the target product profile, the clinical and regulatory path to registration, and the evidence package required for approval. Continuously pressure-test that strategy against emerging data, the competitive landscape, and evolving regulatory expectations, and recommend course corrections early.

Cross-Functional Team Leadership: Lead the MGX-001 core team, coordinating the clinical development, regulatory, CMC development and GMP manufacturing, and preclinical and translational sciences workstreams while considering the input of Key Opinion Leaders (KOLs) and other company strategic advisors. Chair core team meetings, drive decisions to closure, resolve competing priorities across functions, and hold each workstream accountable to its deliverables and timelines.

Integrated Planning, Timeline & Budget: Develop and maintain the detailed integrated program plan with a clear understanding of the critical path, while working with finance to understand and manage the program budget. Model timeline and resource scenarios to inform executive decisions and surface risks with concrete mitigation options.

Regulatory Strategy & Health Authority Interactions: Partner with the medical and regulatory leads to execute the regulatory strategy, including expedited pathway opportunities. Own program readiness and content for Type B and Type C meetings, IND amendments, pre-BLA interactions, and the BLA submission itself as well as applications for orphan drug, RMAT and other appropriate FDA designations, and similar applicable international meetings and designations.

Quality, Compliance & Manufacturing Readiness: Ensure quality and GXP compliance in all development phases, partner with the CMC functions to appropriately plan GMP manufacturing and clinical drug product availability and anticipate all needs and requirements for the trial design and filing strategy.

Executive & Board Communication: Lead and coordinate the team in 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, including direct experience preparing and supporting US and international regulatory submissions including IND, CTA, BLA, and MAA.

Strong program management discipline with integrated timelines, critical path analysis, scenario planning, and budget, applied with judgment rather than as a process for its own sake.

Proven ability to lead through influence in a matrixed environment, including programs where functions such as regulatory or statistics may be delivered by external partners rather than internal staff.

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. You must be comfortable with the demands of a public company, including data disclosure and investor scrutiny, and willing to operate hands-on in a small-company environment.

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.

Under the Federal Labor Standards Act, this position is classified as exempt. Its anticipated base salary range will be $285,000 to $400,000. You will also be eligible to receive an annual bonus, company equity and a full range of benefits. Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.

Metagenomi is proud to be an equal opportunity employer. We are committed to building an inclusive environment for all employees and applicants, and we do not discriminate on the basis of any characteristic protected by applicable federal, state, or local law. This includes, but is not limited to, race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, and traits historically associated with race, including hair texture and protective hairstyles. Harassment or discrimination based on any protected characteristic is strictly prohibited.

Reasonable Accommodation

If you require a reasonable accommodation to participate in the application or interview process, please contact Metagenomi's Human Resources team at View email address on click.appcast.io. We are dedicated to ensuring that all applicants have equal access and opportunity throughout the recruitment process.