The Senior Medical Director, Clinical Sciences, Endocrinology, will play a key role in clinical development programs within the General Medicine portfolio focused on obesity. This role serves as Scientific and Medical Lead for Clinical team(s) working closely with Operational Leads to guide and execute clinical development strategies and subsequent regulatory submissions. This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research. The Senior Medical Director General Medicine reports to an Executive Director, General Medicine.
A typical day in the life of a Senior Medical Director may include the following responsibilities:
- Acts as medical expert and leader in interactions with external stakeholders
- Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops more efficient and innovative, yet robust Phase 2/3 programs.
- Works closely with discovery teams to provide input on the next generation of targets in the field.
- 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 Publications team. 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). Develops written responses to regulatory agency questions and regulatory submission documents.
This role may be for you if you have the following:
- A minimum of an advanced degree in medicine (i.e., M.D. or D.O. or equivalent).
- Clinical training in Endocrinology / Metabolism Practitioner (board certified or eligible or equivalent) is essential.
- A minimum of 6 years of industry experience (majority in late clinical development); however, a candidate with a strong academic background and less experience may be considered.
- Past experience in leading registrational clinical trials, including: protocol design, managing study start-up, directing and guiding study team execution, data cleaning, medical monitoring/review, database locks.
- Experience with regulatory filings and interactions with health authorities
#MDJOBSCD, #GDTherapeuticJobs, #MDJOBS
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$314,100.00 - $424,900.00