Senior Medical Director, Clinical Development, Hematology Oncology

Build our future together:

The Senior Medical Director, Clinical Development provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program in Hematology Oncology with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical communications and publications. This position offers the opportunity to give to a fast-growing, science-driven organization making a significant difference to patients worldwide.

When & where:

• Location: Tarrytown, NY or Warren, NJ
• Travel percentage: 10% to relevant congresses/conferences

Discover your role:

• Manages all operational aspects and drives execution of clinical programs in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates to ensure timely execution of assigned clinical deliverables within approved budget.
• Leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards.
• Ensures overall safety of the compound in collaboration with the Safety Lead for the assigned program.
• Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program.
• Leads development of clinical sections of program level regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions with minimal input from Program Lead MD.

This role requires:

• A M.D. degree, preferably with specialized clinical training in a relevant disease area such as Hematology Oncology
• 4+ years' demonstrated experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4
• Understand global regulatory environment including key regulatory agencies and approval processes
• Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)
• People Management experience preferred but not required.

#MDJobs, #MDJobsCD, #Hematology

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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)