Biomea Fusion
Vice President, Clinical Development
Biomea Fusion, San Carlos, California, United States, 94071
Vice President Of Clinical Development Specializing In Diabetes
We are seeking a highly skilled and experienced Vice President of Clinical Development specializing in Diabetes to lead and oversee our clinical development programs focused on innovative therapies for the management and treatment of diabetes. The ideal candidate will possess a deep understanding of clinical-stage drug development, from first in human through post-approval clinical trials. The position will be responsible for the diabetes clinical development program, including Clinical Operations and Clinical Science teams. The VP Clinical Development will work closely with leadership in other functions, in developing and executing the clinical plan. The candidate should have a deep understanding of diabetes, including its pathophysiology, current treatment landscape, and emerging therapeutic approaches. This individual will play a critical role in shaping our clinical development strategy and driving the successful advancement of our pipeline candidates through all stages of development. This role is onsite 3 days a week. Essential Responsibilities
In collaboration with cross-functional teams, develop and implement a comprehensive clinical development strategy for diabetes indications aligned with the company's overall goals and objectives. Provide strategic oversight and leadership for the clinical development of multiple pipeline candidates targeting various aspects of diabetes, including novel therapeutics and innovative treatment modalities. Lead the design, planning, and execution of Phase I-IV clinical trials, ensuring rigorous study protocols, patient safety, regulatory compliance, and data integrity. Manage Clinical Operations activities, including site selection, investigator recruitment, patient enrollment, and monitoring, to ensure timely and successful completion of clinical trials. Analyze clinical trial data, interpret results, and provide strategic insights to inform decision-making regarding the advancement of pipeline candidates. Collaborate with regulatory affairs teams to prepare and submit regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), as well as responses to regulatory inquiries and requests. Work closely with cross-functional teams, including preclinical development, medical affairs, and external partners, to integrate clinical development plans with overall product development and commercialization strategies. Work closely with medical affairs to help drive the preparation of scientific publications, presentations, and other communication materials to disseminate clinical trial findings and contribute to scientific knowledge in the field of diabetes. Build and maintain relationships with key opinion leaders (KOLs) and academic researchers in the field of diabetes to gather insights, facilitate scientific exchange, and enhance the company's reputation and visibility. Manage departmental budgets, allocate resources effectively, and optimize operational efficiency to ensure the timely and cost-effective execution of clinical development programs. Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals. Education and Experience Requirements
MD with board certification in endocrinology, diabetology, or related field preferred. Minimum of eight years of progressive experience in clinical development within the pharmaceutical or biotechnology industry, with a focus on diabetes or related metabolic disorders; at least five years at an executive level. Proven track record of successfully leading clinical development programs from early-stage development through regulatory approval and commercialization. Extensive knowledge of diabetes pathophysiology, current standard of care, and emerging therapeutic approaches. Strong understanding of clinical trial design, execution, and regulatory requirements in the context of drug development. Excellent leadership, communication, and interpersonal skills, with the ability to collaborate effectively across functional teams and influence key stakeholders. Demonstrated strategic thinking, problem-solving, and decision-making abilities. Prior experience in managing and developing high-performing teams. Industry
Biotechnology Employment Type
Full-time Compensation
The expected salary range for this role is $383,000 to $410,000. An individual's position within the range is influenced by multiple factors, including education background, years of relevant industry experience, and market dynamics. These factors will influence the actual salary offered. Base salary is one part of the overall total rewards program, which includes discretionary bonus program, equity awards and comprehensive benefits program.
We are seeking a highly skilled and experienced Vice President of Clinical Development specializing in Diabetes to lead and oversee our clinical development programs focused on innovative therapies for the management and treatment of diabetes. The ideal candidate will possess a deep understanding of clinical-stage drug development, from first in human through post-approval clinical trials. The position will be responsible for the diabetes clinical development program, including Clinical Operations and Clinical Science teams. The VP Clinical Development will work closely with leadership in other functions, in developing and executing the clinical plan. The candidate should have a deep understanding of diabetes, including its pathophysiology, current treatment landscape, and emerging therapeutic approaches. This individual will play a critical role in shaping our clinical development strategy and driving the successful advancement of our pipeline candidates through all stages of development. This role is onsite 3 days a week. Essential Responsibilities
In collaboration with cross-functional teams, develop and implement a comprehensive clinical development strategy for diabetes indications aligned with the company's overall goals and objectives. Provide strategic oversight and leadership for the clinical development of multiple pipeline candidates targeting various aspects of diabetes, including novel therapeutics and innovative treatment modalities. Lead the design, planning, and execution of Phase I-IV clinical trials, ensuring rigorous study protocols, patient safety, regulatory compliance, and data integrity. Manage Clinical Operations activities, including site selection, investigator recruitment, patient enrollment, and monitoring, to ensure timely and successful completion of clinical trials. Analyze clinical trial data, interpret results, and provide strategic insights to inform decision-making regarding the advancement of pipeline candidates. Collaborate with regulatory affairs teams to prepare and submit regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), as well as responses to regulatory inquiries and requests. Work closely with cross-functional teams, including preclinical development, medical affairs, and external partners, to integrate clinical development plans with overall product development and commercialization strategies. Work closely with medical affairs to help drive the preparation of scientific publications, presentations, and other communication materials to disseminate clinical trial findings and contribute to scientific knowledge in the field of diabetes. Build and maintain relationships with key opinion leaders (KOLs) and academic researchers in the field of diabetes to gather insights, facilitate scientific exchange, and enhance the company's reputation and visibility. Manage departmental budgets, allocate resources effectively, and optimize operational efficiency to ensure the timely and cost-effective execution of clinical development programs. Partner with cross-functional teams, including research, regulatory affairs, commercial, and finance, to ensure seamless program execution and achieve shared goals. Education and Experience Requirements
MD with board certification in endocrinology, diabetology, or related field preferred. Minimum of eight years of progressive experience in clinical development within the pharmaceutical or biotechnology industry, with a focus on diabetes or related metabolic disorders; at least five years at an executive level. Proven track record of successfully leading clinical development programs from early-stage development through regulatory approval and commercialization. Extensive knowledge of diabetes pathophysiology, current standard of care, and emerging therapeutic approaches. Strong understanding of clinical trial design, execution, and regulatory requirements in the context of drug development. Excellent leadership, communication, and interpersonal skills, with the ability to collaborate effectively across functional teams and influence key stakeholders. Demonstrated strategic thinking, problem-solving, and decision-making abilities. Prior experience in managing and developing high-performing teams. Industry
Biotechnology Employment Type
Full-time Compensation
The expected salary range for this role is $383,000 to $410,000. An individual's position within the range is influenced by multiple factors, including education background, years of relevant industry experience, and market dynamics. These factors will influence the actual salary offered. Base salary is one part of the overall total rewards program, which includes discretionary bonus program, equity awards and comprehensive benefits program.