Position Summary:
Apply below after reading through all the details and supporting information regarding this job opportunity.
The role of a Vice President, 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 Chief Technical and Quality Officer, the VP, 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:
Influencing Corporate Strategies and decision making to achieve optimal clinical values by developing Biomea's clinical study strategies, driving study executions and outcomes.
Provide strategic inputs into the development of clinical programs following ICH and other Regulatory Guidance, industry practice and aligning with overall corporate objectives and goals.
Collaborate with cross-functional teams to integrate clinical operations plans with broader corporate strategies.
Ability to execute efficiently under conflicting priorities, prioritizing and delivering quality results
Clinical Trial Management:
Oversee the design, planning, and execution of clinical trials, ensuring adherence to timelines, budget, and quality standards following ICH and Regulatory Guidance and industry practice.
Lead the development and implementation of efficient clinical trial protocols, operational plans, and monitoring strategies.
Presenting at scientific leadership and/or investigator meetings as required
Establishing strong professional relationships with research staff, study investigators, and external partners to support optimal quality clinical study outcomes.
Developing processes for selection of service providers and clinical sites, plans for patient recruitment and site monitoring, ensuring all procedures are in place and followed.
Team Leadership and Development:
Build, mentor, and lead a high-performing clinical operations team.
Foster transparent, collaborative and innovative inter and intra department culture, promoting professional growth and development.
Vendor Management:
Establish and maintain strong professional relationships with external vendors, CROs, investigators and other partners involved in clinical trials, ensuring effective execution of the Agreements to manage the internal/external clinical programs.
Negotiate contracts and oversee the performance of vendors to ensure the highest quality of deliverables.
Compliance and Regulatory Oversight:
Oversee theimplementation of 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.
Collaborate with all internal teams to facilitate timely submissions and approvals.
Risk Management:
In collaboration with Quality, identify and mitigate potential risks associated with clinical trial operations and present Risk Mitigation plan to Management on a regular basis.
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, PharmD or equivalent preferred.
Proven 15+ years' experience in clinical operations leadership within the biotechnology or pharmaceutical industry, preferred metabolic/diabetes experience.
Proven track record of successfully conducting early phase to post-approval clinical trials.
In-depth knowledge of global clinical trial management across all phases of development including clinical trial design and executing with Good Clinical industry Practices with applicable SOPs following 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.
Compensation:
The expected salary range for this role is$345,000 to $375,000 USD annually for this role. An individual's position within the range may be influenced by multiple factors, including education, years of relevant industry experience, and market dynamics. These factors will determine the actual salary offered. Base salary is one part of the overall total rewards program, which includes competitive cash compensation, including discretionary bonus program, equity awards and comprehensive benefits program.
Notice to Recruiters
All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring managers, executive team members, or employees. All vendor organizations are required to contact Human Resources department (see below)
In order to become an authorized vendor, all recruitment vendors must have a formal written agreement with Biomea Fusion and must submit resumes directly to the Human Resources department following submittal instructions. Biomea Fusion's receipt or acceptance of an unsolicited resume submitted by vendor organization does not constitute an actual or implied contract between Biomea Fusion and such organization.
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