Senior Director, Regulatory CMC

ABOUT THE COMPANY

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.  

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

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
• Demonstrated experience creating and submitting high quality CTA/IND and BLA/MAA filings for biologics
• Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations, and ICH, FDA and EMA guidelines for biologic products
• Experience with drug-device combination products and/or device constituent parts (e.g., pre-filled syringes, autoinjectors), including familiarity with 21 CFR Part 4 cGMP requirements, design control and human factors expectations, and EU drug-device combination requirements (e.g., MDR Article 117)
• Demonstrated ability to think creatively and strategically, to interpret regulatory guidance and regulations, and to assess regulatory CMC risks and likelihood of success of various strategies
• Ability to collaborate and lead cross-functionally and to develop strong relationships with partners both internally and externally
• Ability to lead and build high functioning teams
• Strong oral and written communication skills with the ability to lead and influence at all levels of the organization
• Exceptional time and project management skills, with the ability to execute plans under pressure in a small, fast-paced environment with tight deadlines.
• Ideal candidates will have pre-commercial through launch experience, within a small company environment.

 PAY RANGE

The salary range for this role is $260,000-$295,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.

WORKING CONDITIONS 

• Prolonged periods of being at a stationary desk or working on a computer
• Assessing the accuracy, neatness, and/or thoroughness of the work assigned
• Communicating with others to exchange information 
• Ability to travel as needed (up to 10%) for conferences, regulatory interactions, corporate and department-wide meetings/needs

We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.