Medical Director/ Senior Medical Director
About The Position
The Medical Director/Sr. Medical Director will work collaboratively across all line functions including Clinical Operations, Medical Affairs, Regulatory Affairs, and Biometrics. In partnership with these groups the Medical Director will be responsible for various aspects of clinical trial development and execution including medical monitoring, study management, Contract Research Organizations (CRO) oversight, study designs, protocol development, and BLA dossier development and defense. The Director/Sr. Director may also act as a representative of DBV in interactions with key opinion leaders, site investigators and regulatory agencies.
Requirements
- M.D. or D.O. degree required
- +2 years of Pharmaceutical Industry or equivalent academic experience with knowledge of medical monitoring, clinical trial methodology and execution is preferred.
- Strong verbal communication skills with the ability to articular medical/clinical concepts across line functions and to external audiences is required.
- Ability to write high quality documents (e.g., protocol sections, regulatory documents, etc.) is highly desired.
- Ability to interact with external and internal stakeholders to support global scientific and business strategies is desired.
Nice To Haves
- Prior experience in allergy and immunology or related therapeutic area is highly desired.
- Immunology and allergy, pediatric or related therapeutic area desirable
Responsibilities
- Serve as medical monitor on assigned clinical trials with responsibilities to ensure appropriate medical/safety monitoring of study subjects in collaboration with CRO medical monitor(s) including listing, data cleaning, protocol deviation reviews and DSMB preparation.
- Draft, review and oversee medical monitoring plans and related SOPs
- Provide CRO oversight of complex protocol procedures such as double-blind placebo-controlled food challenges.
- Interact directly with study sites as needed to ensure proper execution of study protocols as required.
- Attend internal team meetings, representing the medical/clinical function.
- Maintain/build strong scientific and clinical knowledge of assigned indications (e.g., peanut allergy, cow’s milk allergy, etc)
- Contribute to protocol development/study designs across all indications.
- Contribute to BLA dossier preparations and defense.
- Attend external meetings as required such as Medical/Scientific Congresses, Advisory Boards, Investigator meetings, Regulatory Authority meeting, etc.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
