Medical Director, Clinical Development, Cardiovascular at Regeneron Pharmaceuticals, Inc.

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

#MDJOBS, #MDJOBSCD

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)