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  • 1 month ago

jobs description

The Medical Director works with their supervisor and other members of the cross-functional study team to author Genetic Medicines protocols and facilitate execution of study activities and data summarization. Takes lead on collaborations with discovery scientists and translational geneticist colleagues to understand current and emerging targets/genetic medicines programs across a variety of areas... such as rare metabolic and liver diseases, obesity, and NASH/MASH. Provide input on potential disease areas/indications; and craft clinical experiments that corroborate or inform the biology for decision-making purposes and enable clinical development programs. Evolving Genetic Medicines modalities include RNA Interference (RNAi), CRISPR gene editing, AAV gene delivery, and others.

As a Medical Director, a typical day might include the following:

· Leads the cross-functional study team to craft novel clinical development strategy for genetic medicines, including First in Human (FIH), Phase 2, and Phase 3 clinical trials

· Responsible for the relevance and accuracy of medical science underpinning of clinical study based on detailed scientific review and consultation

· Authors, reviews, and finalizes the medical and scientific portions of study strategies and clinical study protocols (CSPs) and amendments

· Authors, reviews, and edits documents related to trials, such as monitoring plans, SAPs, amendments, IRB/IEC submissions and regulatory submissions

· Accountable for timely clinical trial execution, reviewing adverse events, monitoring patient health, and quality of results

· Analyzes the benefits and risk aspects of an assigned therapeutic candidate

· Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety

· Authors clinical sections of communications/documentation for regulatory agencies and may participate in meetings as needed; Conducts detailed literature reviews and analysis of development opportunities from mechanistic, pharmacological and clinical development perspectives

This role may be for you if:

· You want to make an impact delivering genetic medicines for patients with serious diseases

· You have specialist postgraduate clinical training and practice, and scientific research training and with a track record of success

· You demonstrate critical, science-to-medicine translational thinking skills and sound decision making

· You have the ability to work productively in a fast-paced collaborative working environment

To be considered for this role, you must have an M.D. Degree (M.D./Ph.D. Degree preferred) Board Certification/Eligibility in a relevant therapeutic area preferred, along with relevant industry experience. A minimum of 3-4 years of prior industry experience or practice experience, preferably in a research/academic setting. Experience in analysis of clinical and basic research information from a wide range of topics.

This role requires at least 3 days of onsite presence per week.
#MDJOBS, #MDJOBSCD

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)

$275,200.00 - $372,400.00
Tarrytown NY USA

salary-criteria

Apply - Medical Director, Clinical Sciences, Metabolic and Genetic Medicine Tarrytown