VP, Program Lead — Gene Therapy Development

Metagenomi; Emeryville, Northern (CA, KY); Hybrid; USD 285,000 - 400,000; Full time

Job summary

Metagenomi is seeking a senior leader to drive the MGX-001 program from Phase 1/2 through BLA submission, reporting to the CEO in Emeryville with hybrid work options. This role requires strategic vision and hands-on execution to align development, regulatory, and manufacturing activities across the portfolio.

You will lead a cross-functional team, manage integrated timelines, navigate regulatory pathways, and communicate program status to the executive team and Board.

Qualifications

• Advanced degree required (PhD, PharmD, MD, or MS).
• 15 years in biopharma with ≥5 years leading cross-functional drug development teams.
• Experience preparing US and international regulatory submissions (IND, CTA, BLA, MAA).
• Strong program management with integrated timelines and budget.
• Ability to lead through influence in a matrixed environment.
• Public company experience preferred; comfortable with investor scrutiny.
• Hemophilia or rare bleeding disorder experience is a plus; gene therapy preferred.

Responsibilities

• Drive integrated development strategy for MGX-001 from Phase 1/2 through BLA with cross-functional input.
• Lead MGX-001 core team and coordinate clinical development, regulatory, CMC, GMP, and translational sciences.
• Develop and maintain the detailed program plan and budget; model timelines and risks.
• Own regulatory strategy and interactions with FDA and international agencies.
• Ensure quality and GXP compliance across all development phases.
• Provide updates to executive team and Board.

Skills

Cross-functional leadership

Program management

Regulatory strategy

Stakeholder communication

Leadership in matrixed environment

Education

Advanced degree (PhD/PharmD/MD/MS)

Job description

Metagenomi is seeking a senior leader to drive the MGX-001 program from Phase 1/2 through BLA submission, reporting to the CEO in Emeryville with hybrid work options. This role requires strategic vision and hands-on execution to align development, regulatory, and manufacturing activities across the portfolio.

You will lead a cross-functional team, manage integrated timelines, navigate regulatory pathways, and communicate program status to the executive team and Board.