Medical Director, Clinical Sciences, Infectious Diseases
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, New York
- Start date
- Mar 10, 2023
View more
- Discipline
- Clinical, Clinical Research, Science/R&D, Infectious Disease
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The Medical Director, Clinical Sciences is seeking a qualified physician with Clinical Research experience in Infectious Diseases. They will work closely with other members of Global Clinical Development, contributing to the creation of Clinical Development Plans (CDP) that meet international regulatory standards. They will serve as Scientific and Medical Lead for clinical trials in the CDP according to GCP. They will work in close collaboration with Clinical Project Managers and Clinical Trial Managers at the study level, and with Therapeutic Area Program Managers at the CDP level. They design clinical study concepts leading to clinical trial protocols and provide medical/scientific supervision of individual clinical trials, accountable for all deliverables of clinical trials under their direct responsibility. They contribute to scientific advisory boards, study steering committees and safety monitoring boards.
As a Medical Director, a typical day may include the following:
Defines clinical trial-related Clinical Development Program (CDP) goals and objectives and responsible for the relevance and accuracy of medical science underpinning of clinical study concepts (CSC) based on thorough scientific review and consultation with internal and external experts
Reviews and finalizes clinical study concepts for presentation to TA Head and Development Teams
Reviews and finalizes the medical and scientific portions of clinical trial protocols derived from CSCs
Accountable, along with Clinical Trial Management, for timely clinical trial execution and quality of deliverables
Leads and supervises the work of Clinical Team to produce high quality program deliverables on schedule and identifies program risks, creates and implements mitigation strategies
Organizes clinical advisory boards, steering committees and data safety monitoring boards
Reports to clinical teams and therapeutic area heads on clinical trial milestones and establishes the benefit: risk ratio of a therapeutic candidate in CDP-defined indications
Responsible for the analysis of clinical data, including safety monitoring as well as all activities and procedures that ensure patient safety in compliance with FDA, EMEA, ICH and GCP guidelines
Is the primary clinical contact for communications with regulatory agencies and IRBs/ethics boards
This job may be for you if you have the following:
You possess a rigorous work ethic with focus on details and high-quality results while working effectively under pressure
You are able to work in matrix environment ("dotted- line" authority)
You have superior written, and oral communication skills
You are an innovative thinker with the ability to develop original ideas
In order to be considered for this position you must have a M.D., or equivalent with at least 2 years pharmaceutical industry experience. Candidates with a strong academic background will also be considered. Infectious Disease training (board certified/eligible) is strongly preferred. Available to travel (up to 20% of work time).
#MDJOBS, #MDJOBSCD, #GDTherapeuticJobs
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)
$268,500.00 - $363,300.00Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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