Medical Director, Clinical Sciences, Allergy & Immunology

Overview

The Medical Director, Clinical Sciences is responsible for facilitating assigned studies, providing investigator support of Regeneron driven studies, and may serve as a resource to anticipate and/or resolve study clinical and conduct issues. This role reports into the Clinical Program Lead, Clinical Sciences and is expected to have some knowledge of the drug development process, good clinical practice, study design and research methodology as well as understand Regulatory and compliance landscape in the pharmaceutical industry. This role utilizes scientific and clinical expertise to initiate, propose, design and execute research and development programs for early and/or late-stage assets for immunology indications.

Responsibilities

• Defines clinical trial-related Clinical Development Program (CDP) goals and objectives.
• 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.
• Leads and supervises the work of Clinical Team to produce high quality program deliverables on schedule.
• Organizes clinical advisory boards, steering committees and data safety monitoring boards as required.
• Researches literature for relevant program-related material and informs clinical team of findings.
• Responsible for the analysis of clinical data, including safety monitoring.
• Responsible for all activities and procedures that ensure patient safety.
• Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines.
• Is the primary clinical contact for communications with regulatory agencies and IRBs/ethics boards.

Qualifications

• This job may be for you if you have the following:
• Desire to impact patient populations through innovative drug development.
• Rigorous work ethics with focus on details and high-quality results.
• Works effectively under pressure.
• Ability to work in matrix environment.
• Superior written and oral communication skills.
• Ability to develop original ideas.
• Education and experience: M.D., or equivalent with at least 1-2 years pharmaceutical industry experience. Extensive clinical trial experience in the academic setting can be considered. Allergy, Immunology, Dermatology, Pulmonology training (board certified/eligible) is strongly preferred. We require 4 days a week on-site presence for this role.

Additional Information

Equal opportunity employer statement and on-site policy: 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.

Salary Range (annually): $284,900.00 - $385,700.00.

Other information: 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. Benefits in the U.S. may include health and wellness programs, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves for eligible employees at all levels. For additional information about Regeneron benefits in the US, please speak with your recruiter. Regeneron’s on-site policy for roles likely to be on-site may apply; please speak with your recruiter and hiring manager for more information.

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