Executive Medical Director, Clinical Program Lead, Internal Medicine at Regeneron Pharmaceuticals, Inc.

The Executive Medical Director, Clinical Development, is responsible for effectively executing large, complex studies and programs and serves as an expert resource to anticipate and resolve study/asset clinical and conduct issues. For assigned programs, the incumbent will serve as the Clinical Program Lead (CPL) for one or more compounds in multiple indications driving broader cross functional perspective in the creation of clinical program development strategies. This role reports into the VP, Global Program Head, Internal Medicine, Clinical Sciences and is also leader of select Global Clinical Sub-Teams for the design, implementation, execution and submission/approval of a clinical development program to support decision milestones and regulatory requirements. This role is a clinical subject matter expert for the Clinical Development Unit (CDU) for the assigned program(s) / asset(s).

A typical day in the life of an Executive Medical Director may include the following responsibilities:

• Leader of the Global Clinical Sub-team (GCST) and clinical development representative at the Strategic Program Team (SPT) for assigned assets.
• Independently manages all clinical aspects and drives execution of assigned clinical program(s) in partnership with global line functions and CST and / or SPT members.
• Leads the development and execution of the Clinical Development Plan (CDP) including Phase I III trials designed for successful global registration of the compound. Ensures individual protocols are consistent with CDP and are aligned to achieve the Target Product Profile (TPP).
• Leads creation of clinical components of key documents (regulatory documents, registration dossiers, etc.) supporting registration, market access, and commercialization of the compound(s).
• Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Global Medical Affairs, Marketing, HE&OR), and internal decision boards.
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
• Plans and executes publication and clinical communication strategy in coordination with Scientific Communications. Provides input to key external presentations.
• Ensures quality of all clinical documents (e.g., Investigators Brochure, protocol, study report, clinical components of regulatory submissions, safety related documents) produced by GCST
• Manages, forecasts and allocates resources (FTEs and budget) for the clinical program with support from Development Program Manager. Accountable for timely execution of clinical deliverables within approved budget.
• Ensures career development of functional reports (e.g., Study Medical Directors) and other GD colleagues through active participation in the performance management and talent planning processes. Provides onboarding, training, and mentoring support and contributes to the performance evaluation of GCST members as appropriate.

This role may be for you if you have the following:

• MD or MD/PhD required with relevant clinical fellowship/residency training; >8 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
• 6 years people management experience required, this may include management in a matrix environment.
• Strong management, interpersonal, communication, negotiation and problem solving skills.
• Considerable organization awareness (e.g., inter-relationship of departments, business priorities), including significant experience working cross-functionally.
• Medical/scientific expertise in disease area of assigned program is preferable.
• Understanding of global regulatory environment including key regulatory agencies and approval processes
• Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

#MDJOBSCD, #MDJOBS, #GDTherapeuticJobs

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)