Clinical Study Manager Jobs in Reston, VA (NOW HIRING)

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Medical Director to join our Endocrinology team supporting our Clinical Development Unit. In this role, you will serve as Medical Lead for clinical trials and are responsible for the design of clinical study concepts leading to clinical trial protocols and oversight of studies, while collaborating with cross-functional stakeholders. This role requires a high-performing and highly passionate physician scientist who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

• Location: Tarrytown, NY, Washington, D.C., or Cambridge, MA

• Travel: 10% to relevant conferences

• You provide strategic medical leadership for development programs, driving clinical strategy from early development through registration, including lifecycle management

• You lead the development and execution of integrated clinical development plans, ensuring alignment with scientific, clinical, regulatory, and portfolio objectives

• You are responsible for clinical study concepts and protocol development as well as presentation to internal stakeholders at governance and external at scientific conferences and strategic partnerships

• You lead the Global Clinical Study Team to identify and mitigate clinical, scientific, operation, and safety risks while ensuring high quality execution

• You oversee the medical monitoring of clinical trials to ensure patient safety and adherence to regulatory guidance

• You input and provide clinical/scientific interpretation during the development and analysis of the clinical data, including oversight of data review, clinical study reports, and publications

• An M.D. or equivalent with board eligibility or board certification in Endocrinologystrongly preferred; relevant experience can be acceptable.

• At least 4 years pharmaceutical industry experience (equivalent research in academia will be considered)

• Ideally experience in rare disease drug development preferred

• Previous interactions with regulatoryagencies or common technical document (CTD or "dossier") submission in an ICH region is an advantage

• Strong communication skills and problem-solving abilities

#MDJobsCD, #MDJobs, #GDTherapeuticJobs, #Obesity

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)