What are the responsibilities and job description for the Vice President Clinical Operations position at Marea Therapeutics?
Description
ABOUT THE COMPANY
Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardiometabolic disease targets. Our therapies have the potential to complement existing therapies and serve as transformative treatment options for significant patient populations living with cardiometabolic diseases.
Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of life science investors including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures. The company’s lead program is in Phase 2 clinical development (MAR001) and a second program is progressing towards clinical development in a rare cardiometabolic disease. Marea is a fast-growing company looking for extraordinary individuals to join our team who want to make a difference in the lives of millions of people living with cardiometabolic diseases. The company is led by a dynamic team of scientists and company builders with deep knowledge and experience in cardioendocrine diseases, human genetics, and adipocyte biology.
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
The VP Clinical Operations will play a pivotal leadership role in overseeing the strategy, execution and operational excellence of all clinical trials for Marea. This critical position will drive the development and management of high-performing, Clinical Operations teams, ensuring seamless execution of trials from Phase 1 through Phase 4 in the cardiovascular and endocrine therapeutic areas. The VP will work closely with senior leadership, Clinical Development, Project Management, Biometrics, Regulatory Affairs, and Medical Affairs to align clinical trial strategies and execution with corporate objectives. A key focus of this role will be the preparation and execution of a large-scale (>5,000 patient) Phase 3 Cardiovascular Outcomes Trial, requiring exceptional expertise in trial design, operational efficiency, regulatory compliance, and team resourcing to ensure timely and high-quality study execution.
This is a full time exempt position with a preference for candidates who can regularly work in the South San Francisco-based office.
Requirements
KEY RESPONSIBILITIES
The salary range for this role is $270,000-$315,000. Title and compensation will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
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.
ABOUT THE COMPANY
Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardiometabolic disease targets. Our therapies have the potential to complement existing therapies and serve as transformative treatment options for significant patient populations living with cardiometabolic diseases.
Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well funded by a syndicate of life science investors including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures. The company’s lead program is in Phase 2 clinical development (MAR001) and a second program is progressing towards clinical development in a rare cardiometabolic disease. Marea is a fast-growing company looking for extraordinary individuals to join our team who want to make a difference in the lives of millions of people living with cardiometabolic diseases. The company is led by a dynamic team of scientists and company builders with deep knowledge and experience in cardioendocrine diseases, human genetics, and adipocyte biology.
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
The VP Clinical Operations will play a pivotal leadership role in overseeing the strategy, execution and operational excellence of all clinical trials for Marea. This critical position will drive the development and management of high-performing, Clinical Operations teams, ensuring seamless execution of trials from Phase 1 through Phase 4 in the cardiovascular and endocrine therapeutic areas. The VP will work closely with senior leadership, Clinical Development, Project Management, Biometrics, Regulatory Affairs, and Medical Affairs to align clinical trial strategies and execution with corporate objectives. A key focus of this role will be the preparation and execution of a large-scale (>5,000 patient) Phase 3 Cardiovascular Outcomes Trial, requiring exceptional expertise in trial design, operational efficiency, regulatory compliance, and team resourcing to ensure timely and high-quality study execution.
This is a full time exempt position with a preference for candidates who can regularly work in the South San Francisco-based office.
Requirements
KEY RESPONSIBILITIES
- Oversee all Marea clinical operations and trials from Phase 1 to Phase 4 and ensure delivery of trials within timelines and budgets, with high quality
- Build, develop, and lead the clinical operations team to support multiple development projects, including mentoring of direct reports and others across the development organization
- Develop clinical trial execution strategy and long-range plans ensuring trials are conducted on time, efficiently and cost-effectively
- Work closely with Project Team Leads and other functional heads to ensure alignment across the project portfolio
- Bring a strategic mindset to the project teams by proactively scenario-planning and identifying risks and mitigations
- Support Regulatory Affairs to ensure timely, high-quality study-related submissions
- Partner with Clinical Development, Medical Writing, and Preclinical/Translational teams to develop protocols, clinical study reports, and other trial-related documentation
- Partner with Biostatistics and Data Management to develop case report forms and efficient data collection processes and procedures for clinical trials
- Partner with CMC to ensure appropriate clinical trial supply
- Partner with Quality Assurance to ensure appropriate quality systems are implemented and maintained within the clinical operations function, and to develop and maintain clinical SOPs
- Oversee evaluation and selection of CROs, clinical sites, and other clinical trial vendors/partners
- Lead vendor governance of multiple CRO and clinical study partners
- Develop and manage clinical operations budget and resources
- Ensure compliance with GCP, internal SOPs, and regulatory requirements in conduct of Marea clinical trials
- Serve as a key liaison with internal and external clinical trial stakeholders, including vendor management and oversight
- Promote curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced, performance-driven environment
- B.S. in science or related field
- 15 years of experience in clinical operations; 7-10 years in leadership roles ideally leading cardiovascular/metabolic or large scale, long-term clinical trials
- Experience developing, implementing, and executing clinical development and operations plans
- Exposure to drug development in both large pharma and small biotech companies is highly desired
- Extensive team building and people leadership experience in high growth organizations
- Demonstrated ability to establish working relationships with cross-functional groups and to reach common understanding on development, manufacturing, and quality issues
- Comprehensive knowledge of current industry trends and regulatory expectations associated with biologics drug development and manufacturing
- Experience planning and executing large Phase 3 cardiovascular outcomes trials is strongly preferred, or alternatively experience successfully conducting large global Phase 3 clinical trials in other indications
- Experience supporting regulatory filings (e.g. INDs, BLAs, MAAs, etc.) and interacting with regulatory agencies, including FDA and EMA
- Excellent interpersonal skills with ability to lead, influence, resolve conflict, and drive consensus among people at various levels within the organization and from a variety of functions
- Excellent communication skills with the proficiency to efficiently and productively communicate both orally and in writing, including presentations
The salary range for this role is $270,000-$315,000. Title and compensation will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
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.
Salary : $270,000 - $315,000
