Medical Director
Position Summary
We are seeking a Medical Director that is highly motivated to join our team and work on-site at an exciting biotech start-up in Redwood City. The primary role of the Medical Director will be to lead and execute early/late-stage clinical trials for Biomea’s hematology/oncology products in development. The Medical Director will participate in the design and planning of clinical studies and help with the interpretation of study results. The Medical Director establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. The Medical Director may recruit clinical investigators for research studies. Additional responsibilities include adverse event reporting and safety monitoring. The Medical Director monitors adherence to protocols and determines study completion.
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., biostatistician, clinical operations, medical writing).
- 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 other 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 hematology/oncology products in development.
- 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.
Education and Experience Requirements
- MD with board certification or eligibility in Oncology or Hematology/Oncology.
- At least three years of drug development experience in biotechnology or pharmaceutical industry, or a combination of academia and industry. Note: Individuals with extensive academic experience but without experience in the pharmaceutical industry may be considered
- Hands-on experience in the design, execution, and reporting of controlled clinical trials in oncology.
- Participated in clinical oncology studies with molecular targeted or immunological therapies.
- Understanding of basic science relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
- 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.
- Strong interpersonal, influencing, presentation, and written and verbal communication skills
- Strong organizational and time management skills
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.