Medical Director, Clinical Development, Immunology & Inflammation

The Medical Director, Clinical Development should be a qualified physician with pharmaceutical industry experience, preferably in Immunology & Inflammation Therapeutics Development, to work on late phase cat and birch allergy studies. 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 are responsible for the design of clinical study concepts leading to clinical trial protocols and also for the medical/scientific supervision of individual clinical trials, accountable for all deliverables of clinical trials under her/his direct responsibility. They contribute to scientific advisory boards, study steering committees and safety monitoring boards.

A typical day in the life may include the following 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

• 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 CTM, 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

• Identifies program risks, creates and implements mitigation strategies

• Maintains and develops relationship with key program investigators

• Organizes clinical advisory boards, steering committees and data safety monitoring boards as required

• Reports to clinical teams and TAH on clinical trial milestones

• Responsible for the medical content of clinical study reports

• Reviews all medical/scientific publications related to clinical trials

• Researches literature for relevant program-related material and informs clinical team of findings

• Establishes the benefit: risk ratio of a therapeutic candidate in CDP-defined indications

• 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

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

• Recognized expertise in developing Immunology & Inflammation therapeutics

• Has working knowledge of GCP, ICH, US FDA and EMEA regulations

• Successfully conducted exploratory clinical and/or confirmatory development

• Rigorous work ethics with focus on details and high-quality results

• Works effectively under pressure

• Ability to work in matrix environment

• Ability to manage clinical trial resources

• Superior written, and oral communication skills;

• Ability to develop original ideas

• Available to travel (up to 20% of work time)

In order to be considered for this position you must have a 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.

#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 accom