Senior Program Lead, Gene Therapy Clinical Development

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

Job summary

Metagenomi Therapeutics, Inc. is seeking a Program Lead for MGX-001 in Emeryville, CA. This hands-on role will drive the strategy and schedule from Phase 1/2 through BLA, coordinating clinical, regulatory, CMC, and manufacturing workstreams.

You will report to the CEO and guide the program in a fast-paced public company setting. The candidate will manage cross-functional teams, ensure regulatory readiness, and oversee budget while navigating HEOR and investor expectations.

Qualifications

• Advanced degree in life sciences (PhD/MD/PharmD/MS) required.
• 15+ years in biopharmaceuticals with 5+ years leading cross-functional drug development teams or programs.
• Experience preparing US and international regulatory submissions (IND, BLA, MAA).
• Strong program management with integrated timelines and budget.
• Ability to lead through influence in a matrixed environment.

Responsibilities

• Drive integrated development strategy for MGX-001 from Phase 1/2 through BLA.
• Lead MGX-001 core team across clinical, regulatory, CMC, and manufacturing workstreams.
• Develop and maintain the detailed program plan and budget.
• Lead regulatory strategy and interactions with health authorities.
• Ensure quality, compliance, and GMP readiness throughout development.
• Communicate program status to executive team and Board.

Skills

Program management

Cross-functional leadership

Regulatory submissions

GCP/GMP knowledge

Public company experience

Hemophilia experience

Education

Advanced degree in life sciences

Job description

Metagenomi Therapeutics, Inc. is seeking a Program Lead for MGX-001 in Emeryville, CA. This hands-on role will drive the strategy and schedule from Phase 1/2 through BLA, coordinating clinical, regulatory, CMC, and manufacturing workstreams.

You will report to the CEO and guide the program in a fast-paced public company setting. The candidate will manage cross-functional teams, ensure regulatory readiness, and oversee budget while navigating HEOR and investor expectations.