The Study Medical Director, Clinical Sciences is responsible for facilitating assigned ovarian and/or rare cancer studies, providing investigator support of Regeneron driven studies, and may serve as a resource to anticipate and/or resolve study clinical and conduct issues. This role reports into the Senior Medical Director-Oncology Clinical Development, Clinical Sciences and is expected to have proficient knowledge of the drug development process, good clinical practice, study design and research methodology as well as understand Regulatory and compliance landscape in the pharmaceutical industry. This role utilizes scientific and clinical expertise to initiate, propose, design and execute research and development programs for early and/or late stage assets. This role may be clinical subject matter expert for assigned studies.
A typical day in the life of a Medical Director may include the following responsibilities:
Manages all clinical aspects and drives execution of the clinical studies in partnership with global line functions and Clinical Study Team (CST) members
Authors and approves, with minimal oversight, clinical documents (such as Protocols, ICFs, Medical Monitoring Plan, Statistical Analysis Plan, Safety Management plans and other project implementation plans) with minimal guidance
Supports Clinical Program Lead, (CPL) in ensuring overall safety of the compound in collaboration with the Safety Lead for the assigned program
Provides scientific and medical leadership and is responsible for medical review and approval of external and internal scientific content for assigned studies (e.g., presentations, educational materials, trainings)
In collaboration with Clinical Study Team (CST), completes clinical data reviews and activities prior to data cuts as needed throughout life of study (e.g., interim analyses, DBLs, regulatory submissions, etc.)
Communicates with CRO and study site personnel including investigators to answer/triage clinical, scientific, and protocol -related questions, identify and provide ongoing training as needed
When necessary with senior stakeholders, develops and delivers clear, thorough scientific presentations to internal stakeholders and external communities (including experts, clinical investigators, collaborators etc.)
This job may be for you if you have the following:
MD or MD/PhD required with specialized clinical fellowship training and 0-3 years of related academic or industry experience. Gynecologic oncology experience would be a plus.
For academics, we would seek impactful/high profile publications and/or significant research grants and contributions to basic science and/or clinical research
For industry experience, we would seek experience with medical monitoring and protocol design for clinical studies and/or equivalent experience
Demonstrated ability to influence cross functional teams and lead activities within a matrix environment
Ability to communicate concise and clear messages
Ability to identify critical risks and mitigation
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