Head of Gene Therapy Program Strategy

Metagenomi Therapeutics Inc.; Emeryville (CA); Hybrid; USD 285,000 - 400,000; Full time

Job summary

Metagenomi Therapeutics Inc. in Emeryville, CA is seeking a Program Lead for MGX-001 to drive the strategic vision from Phase 1/2 through BLA filing. You will report to the CEO and lead a cross-functional team in a fast-paced public company environment.

The role requires an advanced life sciences degree and 15 years in biopharma, including 5 years leading drug development programs and regulatory submissions. Domestic/international travel is required with hybrid work options.

Qualifications

• Advanced degree in a life sciences field (PhD, PharmD, MD, or MS).
• 15+ years in biopharma, with 5+ years leading cross-functional drug development programs.
• Experience preparing and supporting US/international regulatory submissions (IND, CTA, BLA, MAA).
• Strong program management with timelines, critical path analysis, and budgeting.

Responsibilities

• Drive integrated development strategy for MGX-001 from Phase 1/2 through BLA.
• Lead cross-functional MGX-001 core team and coordinate clinical development, regulatory, CMC, and manufacturing workstreams.
• Develop and maintain the integrated program plan and budget; model timelines and risks.
• Manage regulatory strategy and interactions with health authorities, including meetings and designations.
• Ensure GxP compliance and align quality/manufacturing with the clinical plan.
• Provide updates to executive team and Board on program status.

Skills

Program management

Cross-functional leadership

Regulatory strategy

Executive communication

Leadership in matrixed environment

Education

Advanced life sciences degree

Tools

GXP knowledge

Job description

Metagenomi Therapeutics Inc. in Emeryville, CA is seeking a Program Lead for MGX-001 to drive the strategic vision from Phase 1/2 through BLA filing. You will report to the CEO and lead a cross-functional team in a fast-paced public company environment.

The role requires an advanced life sciences degree and 15 years in biopharma, including 5 years leading drug development programs and regulatory submissions. Domestic/international travel is required with hybrid work options.