Medical Director, Clinical Sciences, Ophthalmology - Regeneron Pharmaceuticals, Inc.

The Medical Director of Clinical Sciences should be a qualified physician with pharmaceutical industry experience, within Ophthalmology Therapeutics Development. You will work closely with other members of Global Clinical Development, contributing to the creation of Clinical Development Plans (CDP) that meet international regulatory standards. Will work with the clinical team running clinical trials in the CDP according to GCP. Work in close collaboration with Clinical Program Operations Lead (POL) and Clinical Trial Managers (CTM) at the study level. Contribute to the design of clinical study concepts leading to clinical trial protocols and also may be responsible for the medical/scientific supervision of individual clinical trials, accountable for all deliverables of clinical trials under direct responsibility. May be a member of a Strategic Program Team and Global Clinical Study teams, and will contribute to scientific advisory boards, study steering committees and safety monitoring boards.

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

• Helps define 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

• Supports the review and finalization of clinical study concepts for presentation to Therapeutic Head, Strategic Program Teams, and internal governance meetings

• 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

• Supports clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety; Supports identification of data trends and potential inconsistencies in data across assigned studies and raises appropriately

• Assists with preparation of documents related to trials, such as medical monitoring plans, SAPs, informed consents, Clinical Study Reports and regulatory documents

• Identifies programs clinical risks, creates and implements mitigation strategies

• 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 indication

• Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines

• Supports communications with regulatory agencies and IRBs/ethics boards

• Identifies and recommends resource allocation for clinical operation plan (COP) execution and helps establishes and monitor COP budget

• Recognized expertise in developing ophthalmic therapeutics

• Rigorous work ethics with focus on details and high-quality results and works effectively under pressure

• Able to lead by influence, develop and communicate a vision and foster commitment in team members and peers

To be considered for this role, you must have an M.D., Board-eligible or board certified in Ophthalmology and at least 2 years pharmaceutical industry experience. Experience in Ophthalmic Drug Development is preferred. Previous interactions with Regulatory agencies or Common technical document (CTD or "dossier") submission in any ICH region is an advantage. Available to travel (up to 20% of work time). Possess superior written and oral communication skills. We are seeking working knowledge of GCP, ICH, US FDA and EMEA regulations. Working understanding of statistical principles.

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)