We are seeking a Medical Director/Sr. Medical Director Diabetes with a deep and comprehensive understanding of diabetes clinical trial development and execution, to lead and execute early- and late-stage programs in both type 1 and type 2 diabetes. This individual will be responsible for leading the medical and scientific strategy across the clinical development lifecycleincluding trial design, planning, oversight, and data interpretation. The Medical Director will ensure the scientific integrity and operational excellence of clinical protocols, data collection systems, and final study reports and will contribute strategic insight based on in-depth therapeutic area expertise.
The Medical Director/Sr. Medical Director will also collaborate closely with cross-functional teams including Medical Affairs, Scientific Communications, Regulatory Affairs, Clinical Operations, Biostatistics, and Safety/Pharmacovigilance. The Medical Director will play an important role in planning and delivering key data disclosures (i.e. abstracts, presentations, peer-reviewed publications) and be responsible for oversight of scientific content related to study outcomes and publications. The successful candidate will bring hands-on experience in managing the complexities of diabetes trials and will be instrumental in guiding study design decisions that reflect current best practices in diabetes therapeutics and technologies. Additional clinical trial-related responsibilities include collaborating closely with the Safety and Pharmacovigilance team for adverse event reporting, safety & medical monitoring, as well as working closely with the Clinical Operations team in study site selection and investigator training. This role is required to be on-site 3 days a week.
Essential Responsibilities:
- Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, GCP and good medical practice.
- Work collaboratively with other clinical staff in trial execution and oversight (e.g., Biostatistics, Regulatory, Clinical Operations, Drug Safety and Scientific Communications).
- Act as Medical Monitor for company-sponsored trials.
- Support project teams with therapeutic area-specific information.
- Collaborate with internal departments in analyzing and reporting of safety data from clinical trials.
- Support writing and review of investigator brochures, protocols, statistical analysis plans, and clinical study reports.
- Analyze and interpret clinical trial data and prepare reports for regulatory agencies and publication.
- Interact with key opinion leaders and investigators in relevant disease-specific areas.
- Ensure consistency of scientific and development strategies for diabetes products in development.
- Collaborate with Medical Affairs and other groups within the organization to successfully execute KOL strategy, advisory boards, and scientific activities at conferences.
- Maintain the highest level of scientific and clinical knowledge in diabetes and related metabolic disorders.
- May supervise employees, both directly and indirectly, through a dotted line structure.
Education and Experience Requirements:
- MD with board certification in Endocrinology, Diabetes or Metabolism.
- At least three to five years of drug development experience in the biotechnology or pharmaceutical industry, or a combination of academic and industry experience.
- Proven, hands-on experience in the design, execution, and reporting of clinical trials in diabetes mellitus (type 1 and type 2).
- Demonstrated deep understanding of diabetes clinical trial development processes, including regulatory requirements and global study execution.
- Experience with diabetes-related technologies, such as insulin pumps and continuous glucose monitors, either in clinical practice or clinical research.
- Proven ability to effectively operate in a cross-functional/matrixed environment.
- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
- Ability to develop and maintain relationships with significant key opinion leaders.
- Excellent interpersonal, influencing, presentation, and written and verbal communication skills.
- Strong organizational and time management skills.
- Travel up to 20% of the 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 $310,000 to $350,000. An individuals position within the range is influenced by multiple factors, including education background, years of relevant therapeutic and industry experience, location 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.
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