- 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, Clinical Operations, 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 area.
- 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 key opinion leader strategy, advisory boards, scientific activities at scientific conferences, and other medical affairs-related activities.
- Maintain the highest level of scientific and clinical knowledge in relevant disease specific area.
- May supervise employees, both directly and indirectly through a dotted line structure.
- MD with board certification or eligibility in Endocrinology, Diabetes and Metabolism
- At least three years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry
- Proven hands-on experience in the design, execution, and reporting of controlled clinical trials in diabetes mellitus (both type 1 and type 2 diabetes)
- Experience with diabetes-related technology such as insulin pumps and continuous glucose monitors (in clinical practice and/or in the context of clinical trials)
- Proven ability to effectively work in a cross-functional/matrix 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.
- Develops technical and/or business solutions to complex problems.
- Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
- 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 time
- Biotechnology
- Full-time
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Medical Director - Redwood City, United States - Biomea Fusion Inc.
Description
Position Summary:
We are seeking a Medical Director that is highly motivated to join our team and work on-site at an exciting biotech company based in Redwood City.
The primary role of the Medical Director will be to lead and execute early- and late-stage clinical trials in type 1 and type 2 diabetes.
The Medical Director will participate in the design and planning of clinical trials, medical aspects of trial execution and play an integral role in interpretation of study results.
The Medical Director will establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final study reports.
In close collaboration with Medical Affairs and Scientific Communications teams, the Medical Director will play an important role in planning and delivering key data disclosures (i.e., abstracts, presentations, peer-reviewed publications).
In addition, the role will work closely with Medical Affairs and have a significant role in Key Opinion Leader identification and development, advisory boards, scientific congresses, and fostering relationships with scientific associations and patient advocacy groups.
Additional clinical trial-related responsibilities include collaborating closely with the Safety and Pharmacovigilance team for adverse event reporting and safety monitoring and working closely with the Clinical Operations team in study site selection.
Essential Responsibilities:
Education and Experience Requirements:
Note:
Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered
Industry:
Employment Type:
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 the Medical Director role is $285,000 to $310,000.
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.
