Vice President, Technical Development

Marea Therapeutics • South San Francisco, CA

4d • $340,000 - $360,000 • Hybrid

About The Position

Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases. The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year. At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.

Requirements

• BS, MS, or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Chemistry, or a related field; a Ph.D. is not required but is highly desirable
• 15–20 years of biotechnology or pharmaceutical industry experience
• Significant leadership experience across two or more of: Upstream Process Development, Downstream Process Development, Analytical Development, or Drug Product/Formulation Development
• Demonstrated success advancing products from early development through late-stage clinical development
• Strong understanding of GMP regulations, CMC requirements, and regulatory submissions
• Experience managing CDMOs and external development partners
• Experience building, leading, and mentoring multi-disciplinary technical development teams
• Demonstrated skills in working cross functionally (example, prior experience as a CMC team lead for a late stage product is a plus)

Nice To Haves

• Drug Product/Formulation development experience is a significant plus and may expand the scope of this role

Responsibilities

• Provide strategic and operational leadership across the Upstream Process Development, Downstream Process Development, and Analytical Development functions
• Working with CDMO and external partners, ensure delivery of all work packages covering process, analytical development, tech transfer, scale up, technical content for global regulatory submissions
• Lead, mentor, and develop the function heads and teams responsible for each of these areas
• Develop and execute an integrated technical development strategy that is synchronized with the cross functional project team's plans and translated into executable SOWs with external partners
• Lead technical development from IND-enabling stages through late-stage clinical development
• Provide strategic input to portfolio planning, development timelines, and investment decisions
• Oversee upstream and downstream process development, characterization, scale-up, and technology transfer activities
• Ensure development of scalable, cost-effective, and compliant manufacturing processes
• Direct analytical method development, qualification, validation, and comparability strategy across programs
• Manage external manufacturing organizations and technical service providers supporting upstream, downstream, and analytical activities
• Provide CMC leadership for regulatory submissions, including INDs, BLAs, NDAs, and other global filings, with particular focus on upcoming IND/BLA-enabling agency interactions for Marea's pipeline
• Author and review CMC sections of regulatory documents within the function's scope
• Support agency interactions related to manufacturing, process development, and product quality
• Partner with Quality Assurance to maintain GMP compliance across all development and manufacturing activities within scope
• Support inspection readiness and responses to regulatory observations
• Partner closely with Manufacturing, Supply Chain, Regulatory Affairs, and Clinical Development to ensure alignment across the broader technical operations organization
• Oversee budgets and build, mentor, and retain a high-performing technical development organization
• If Drug Product/Formulation Development is added to scope: oversee formulation development, drug product process development, and related CDMO relationships
• Actively participate in cross functional CMC and Project teams and guide strategies and plans

Benefits

• In compliance with applicable pay transparency laws, the expected base salary range for this position is $340,000 to $360,000 annually.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree