SVP, Clinical Operations

Position Summary:

The role of a SVP, Clinical Operations will play a pivotal role in shaping and executing the clinical development strategy and operational leadership of Biomea Fusion. Reporting directly to the President & COO, the SVP, Clinical Operations will lead and build a high-performing team to ensure the successful planning, implementation, and management of clinical trials across Biomea's Diabetes and Obesity programs. This is an onsite role based in Redwood City, CA.

Key Responsibilities:

Strategic Leadership:

• Develop Biomea's clinical study strategy and drive study execution
• Provide strategic input into the development of clinical programs, aligning with overall corporate objectives and goals.
• Collaborate with cross-functional teams to integrate clinical operations plans with broader corporate strategies.

Clinical Trial Management:

• Oversee the design, planning, and execution of clinical trials, ensuring adherence to timelines, budget, and quality standards.
• Develop and implement efficient clinical trial protocols, operational plans, and monitoring strategies.
• Present at scientific leadership and/or investigator meetings as required
• Establish strong relationships with research staff, study investigators, and external partners to support clinical studies and drive enrollment.
• Develop patient recruitment plans and monitor enrollment, ensuring all procedures are in place.

Team Leadership and Development:

• Build, mentor, and lead a high-performing clinical operations team.
• Foster a collaborative and innovative culture within the department, promoting professional growth and development.

Vendor Management:

• Establish and maintain strong relationships with external vendors, CROs, investigators and other partners involved in clinical trials, ensuring effective execution of internal/external clinical programs.
• Negotiate contracts and oversee the performance of vendors to ensure the highest quality of deliverables.

Compliance and Regulatory Oversight:

• Oversee implement quality checks for clinical projects, ensuring compliance with company SOPs, ICH-GCP guidelines, regulatory requirements, patient safety standards and industry standards in the conduct of clinical trials.
• Work closely with regulatory affairs to facilitate timely submissions and approvals.

Risk Management:

• Identify and mitigate potential risks associated with clinical trial operations
• Implement proactive risk management strategies to ensure trial success.

Resource Planning and Budgeting:

• Develop and manage budgets for clinical operations, ensuring optimal resource allocation.
• Provide regular updates on budgetary performance and variance analysis.

Education and Experience Requirements:

• Advanced degree in life sciences including biology, pharmacology, or a related field; MD, PhD, or equivalent preferred.
• Proven 15 years' experience in clinical operations leadership within the biotechnology or pharmaceutical industry, metabolic/diabetes experience preferred.
• Proven track record of successfully bringing a product to market,
• In-depth knowledge of global clinical trial management across all phases of development, clinical trial design, conduct, Good Clinical Practices, applicable SOPs, and regulatory requirements.
• Strong leadership and management skills with a track record of building and leading successful teams.
• Demonstrated ability to navigate complex decision-making processes and drive results.
• Collaborative, team-oriented mindset with excellent verbal and written communication and interpersonal skills.

Industry:

• Biotechnology

Employment Type:

• Full-time

Equal Employment Opportunity:

At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.