Sr Medical Director, Clinical Development, Hematology at Regeneron Pharmaceuticals, Inc.

The Senior Medical Director, Clinical Sciences, Hematology provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program 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.

A day in the life may include the following responsibilities:

• Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates.

• Ensures timely execution of assigned clinical deliverables within approved budget.

• Supports Program Lead MD and frequently lead 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.

• Supports Program Lead MD in ensuring overall safety of the compound in collaboration with the Safety Lead for the assigned program.

• Contributes to CRFs, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program.

• Contributes/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.

• Ensures career development of GCD colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of GCST members as appropriate.

• Serves frequently as member for GCD training programs, author or reviewer for clinical SOPs. May contribute to GCD strategy by serving on taskforces or other panels.

This job may be for you if you:

• Want to impact patients by developing new and innovative therapies

• Have strong management, interpersonal, communication, negotiation, and problem-solving skills

• Considerable organization awareness, including significant experience working cross functionally

• Have medical/scientific expertise in the disease area of assigned program

• 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)

In order to be considered for this position, you must have an M.D. preferably with clinical training in a relevant disease area- Malignant and Non-malignant Hematology, or Immunology/Rheumatology. More than 5 years' experience in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases 1 through 4 is also required as well as people management experience in a matrixed environment. This role requires 3 non-consecutive days on-site weekly.

#MDJOBSCD, #MDJOBS #Hematology

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)