Description

The Senior Medical Director will play a key role in clinical development programs within the Ophthalmology portfolio, including being accountable for deliverables of the assigned program(s), supporting resourcing, budget, and timelines of these programs. This role serves as scientific and medical lead for clinical team(s) working closely with operational leads. 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 incumbent will collaborate with multi-disciplinary clinical teams, assisting in guiding and executing clinical development strategies and subsequent regulatory submissions. This role is responsible for the design and execution of first-in-human through registration-enabling studies. This role will serve as a representative to a range of audiences, including Internal Medicine leadership, executive leadership, development partners, and US and global regulatory agencies. The Senior Medical Director, Ophthalmology reports to the Vice President, Ophthalmology Therapeutic Area Lead.

A typical day in the life of a Senior Medical Director, Clinical Development may include the following:

Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Global Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards.
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 1, 2, and 3 programs.
Works closely with the research and 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.
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 prepares regulatory submission documents.
Has strong consensus-building skills and the ability to collaborate with multi-disciplinary teams towards sound decision-making. Key member of dynamic and matrixed clinical teams in a fast-paced and hands-on environment.

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

A M.D. or D.O. or equivalent medical degree and relevant training
A trained Ophthalmologist (board certified or eligible or equivalent) is essential.
A minimum of 4 years of industry experience (early or late clinical development); however, a candidate with a strong academic background and less experience may be considered.
Experience in leading proof of concept and/or registrational clinical trials, including protocol design, managing study start-up, directing, and guiding study team execution, data cleaning, medical monitoring/review, database locks.
Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidate products is required.
A strong commitment to clinical research and the ability to work well within a team setting are essential.
This role requires 4 days a week on-site in Tarrytown, NY, Cambridge, MA, or Warren, NJ

#MDJobs, #MDJOBSCD, #GDTherapeuticJobs, SKC

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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)

$333,300.00 - $450,900.00

Senior Medical Director, Clinical Development, Ophthalmology

Description

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