Description : 

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.

Location : Warren - NJ,

Salary Range : 250K-300K

Key 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.

• 10% Travel (US/FRA)

Qualifications : 

• 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.

• Prior experience in allergy and immunology or related therapeutic area is highly desired.

• Immunology and allergy, pediatric or related therapeutic area desirable

• 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.

Behavioral skills : 

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,

• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,

• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,

• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology.