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Job description
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 validatedcardioendocrinedisease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living withcardioendocrinediseases.
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.
ABOUT THE ROLE
We are seeking a motivated Senior Director, Regulatory Chemistry, Manufacturing, and Controls (CMC) to be responsible for the development of regulatory strategies and submissions related to the manufacturing of our products in the US and globally. The incumbent will be responsible for overseeing Regulatory CMC aspects of Marea’s product development, manufacturing, and eventual commercialization efforts.
The position requires a strong ability to both think strategically and manage hands on execution, working well independently and in collaboration with internal and external cross-functional teams. The position reports to the Executive Director, Regulatory Affairs and will be involved in the future development and growth of the Regulatory CMC function. The role will also serve as a member of the Tech Ops leadership team to keep CMC strategy aligned with the company's overall regulatory strategy, with a dotted-line reporting relationship to the CTO.
This is a full-time position, with a strong preference for candidates that can work on-site at least two days per week in the San Francisco-based office.
KEY RESPONSIBILITIES
Provide regulatory CMC strategic leadership to support development of Marea’s programs
Partner with key functional heads in Technical Operations (Process/Analytical/Formulation Development, Manufacturing, Quality and Supply Chain) and other cross-functional stakeholders to ensure alignment of regulatory strategies with manufacturing and development activities
Support development of manufacturing and control strategies for development products, including assessing proposed manufacturing process and analytical method changes and provide strategic regulatory guidance on phase appropriate considerations and comparability needs
Lead CMC regulatory strategy for drug-device combination products and device constituent parts, including future pre-filled syringes and autoinjectors, in coordination with Device Development, Drug Product Development and Quality
Serve as the Regulatory Affairs representative on CMC teams and committees
Lead communications with regulatory agencies related to CMC strategies and issues
Manage and implement planning, authoring, and submission of high-quality CMC‑related briefing documents and CMC portions of regulatory applications in the US and globally
Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines; identify regulatory risks
Maintain CMC Regulatory document control system
Monitor regulatory guidelines and trends related to CMC; interpret regulations and guidance to provide advice to company leadership and CMC teams
Facilitate timely responses to information requests and questions from health authorities regarding CMC
Proactively identify CMC regulatory risks and propose mitigations that help shape a balanced CMC strategy
Build Regulatory CMC functional capabilities, including growing the future Regulatory CMC team
KEY RESPONSIBILITIES
Provide regulatory CMC strategic leadership to support development of Marea’s programs
Partner with key functional heads in Technical Operations (Process/Analytical/Formulation Development, Manufacturing, Quality and Supply Chain) and other cross-functional stakeholders to ensure alignment of regulatory strategies with manufacturing and development activities
Support development of manufacturing and control strategies for development products, including assessing proposed manufacturing process and analytical method changes and provide strategic regulatory guidance on phase appropriate considerations and comparability needs
Lead CMC regulatory strategy for drug-device combination products and device constituent parts, including future pre-filled syringes and autoinjectors, in coordination with Device Development, Drug Product Development and Quality
Serve as the Regulatory Affairs representative on CMC teams and committees
Lead communications with regulatory agencies related to CMC strategies and issues
Manage and implement planning, authoring, and submission of high-quality CMC‑related briefing documents and CMC portions of regulatory applications in the US and globally
Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines; identify regulatory risks
Maintain CMC Regulatory document control system
Monitor regulatory guidelines and trends related to CMC; interpret regulations and guidance to provide advice to company leadership and CMC teams
Facilitate timely responses to information requests and questions from health authorities regarding CMC
Proactively identify CMC regulatory risks and propose mitigations that help shape a balanced CMC strategy
Build Regulatory CMC functional capabilities, including growing the future Regulatory CMC team
QUALIFICATIONS
15+ years of pharmaceutical or biotech industry experience, at least 10 years of experience in CMC Regulatory Affairs for biologics
Bachelor’s Degree in biochemistry, chemistry, biology, or related pharmaceutical fields; advanced degree preferred
Direct CMC Regulatory Affairs experience supporting monoclonal antibody (mAb) development is required
Direct experience leading CMC interactions with regulatory health authorities
Dem
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Worksite address
south san francisco, CA, 94083, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.