Executive Medical Director, Clinical Development, Obesity
Executive Medical Director, Clinical Development, Obesity
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Job Description
The Executive Medical Director Clinical Sciences Obesity is responsible for effectively executing large and/or complex studies and/or programs and serves as an expert resource to anticipate/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 Internal Medicine Obesity CPL Clinical Sciences and is also leader of select Global Clinical SubTeams 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 CDU for assigned program(s) / asset(s).
A typical day in the life of an Executive Medical Director may include the following:
- Leads the Global Clinical Subteam (GCST) and clinical development representative at the Strategic Program Team (SPT) for assigned assets managing all clinical aspects and driving execution of assigned clinical program(s)
- Leads the development and execution of the Clinical Development Plan (CDP) including Phase I III trials designed for successful global registration of the compound.
- 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 and internal stakeholders
- Ensures safety of the drug including the safety aspects of patients in clinical studies and signal detection from postmarketing surveillance with the support from Global Patient Safety.
- Ensures quality of all clinical documents (e.g. Investigators Brochure protocol study report clinical components of regulatory submissions safety related documents) produced by GCST
- Builds and leads effective teams. Manages and oversees activities of teams up to Senior Medical Director level; Establishes operational objectives and work plans delegating assignments to subordinate staff.
This job may be for you if you have the following:
- MD or MD/PhD required; >8 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through experience may be considered.
- 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. interrelationship of departments business priorities) including significant experience working crossfunctionally.
- Medical/scientific expertise in Endocrinology CV/Metabolism and/or Obesity is strongly preferred.
- Understanding of global regulatory environment including key regulatory agencies and approval processes
- Strong understanding of operational aspects of all phases of clinical trial conduct (startup conduct closeout)
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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 Companys 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 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)
Required Experience:
Director
Employment Type
Full-Time
