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Medical Director, Clinical Development, Cardiovascular
1 month ago
The Medical Director, Clinical Development is responsible for facilitating assigned 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 Clinical Program Lead for Cardio-Renal, 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 a clinical subject matter expert for the Clinical Development Unit assigned studies.
A typical day in the life may include the following:
- 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 creation of clinical sections of regulatory documents, performs quality review, and may approve.
- 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 oversees 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), executes clinical data reviews and activities prior to data cuts as needed throughout life of study (e.g., interim analyses, DBLs, regulatory submissions, etc.).
- Contributes to, reviews, and approves design of EDC data base and edit check specifications/data review listing specifications.
- 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 Board certification or Board eligibility in Cardiology, Nephrology, or Endocrinology. In lieu of subspecialty training, internal medicine training with extensive experience in Cardio-renal or Endocrinology drug development may be considered.
- For academic physician scientists:
- Impactful/high profile publications and/or significant research grants.
- Have made contributions to basic science and/or clinical research.
- For industry experienced physician scientists (0-3 years of industry experience):
- Experience with medical monitoring and protocol design for clinical studies and/or equivalent experience.
- Demonstrated ability to influence team and may influence across function.
- Ability to lead activities within a matrix environment.
- Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally.
- Advanced analytical and influencing skills.
- Ability to communicate concise and clear messages.
- Seeks to understand different perspectives and cultures and values differing points of view.
- Can identify critical risks and mitigation.
- Proficient medical writing skills and advanced presentation skills.
