VP, Program Team Lead

Metagenomi Therapeutics Inc.•Emeryville, CA

4d•$285,000 - $400,000•Hybrid

About The Position

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

Requirements

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.
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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.
Lead and coordinate the team in updates on the MGX-001 program to the executive team and Board.