Director Clinical Development Jobs in Michigan (NOW HIRING)

The Senior Medical Director will play a key role in clinical development programs within the Ophthalmology portfolio, including being accountable for deliverables of the assigned program(s), supporting resourcing, budget, and timelines of these programs. This role serves as scientific and medical lead for clinical team(s) working closely with operational leads. This role requires a high-performing and highly passionate individual who serves as a clinical role model for the team and demonstrates outstanding clinical scientific knowledge applicable to clinical research.

The incumbent will collaborate with multi-disciplinary clinical teams, assisting in guiding and executing clinical development strategies and subsequent regulatory submissions. This role is responsible for the design and execution of first-in-human through registration-enabling studies. This role will serve as a representative to a range of audiences, including Internal Medicine leadership, executive leadership, development partners, and US and global regulatory agencies. The Senior Medical Director, Ophthalmology reports to the Vice President, Ophthalmology Therapeutic Area Lead.

A typical day in the life of a Senior Medical Director, Clinical Development may include the following:

• Acts as medical expert and leader in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards), internal stakeholders (e.g., Research, Global Clinical Development, Global Medical Affairs, Marketing, HEOR), and internal decision boards.
• Develops unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape. Designs and develops more efficient and innovative, yet robust Phase 1, 2, and 3 programs.
• Works closely with the research and discovery teams to provide input on the next generation of targets in the field.
• Ensures safety of the drug, including the safety aspects of patients in clinical studies and signal detection from post-marketing surveillance, with the support from Global Patient Safety.
• Ensures quality of all clinical documents (e.g., investigators' brochure, protocol, study report, clinical components of regulatory submissions, safety related documents).
• Develops written responses to regulatory agency questions and prepares regulatory submission documents.
• Has strong consensus-building skills and the ability to collaborate with multi-disciplinary teams towards sound decision-making. Key member of dynamic and matrixed clinical teams in a fast-paced and hands-on environment.

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

• A M.D. or D.O. or equivalent medical degree and relevant training
• A trained Ophthalmologist (board certified or eligible or equivalent) is essential.
• A minimum of4 years of industry experience (early or late clinical development); however, a candidate with a strong academic background and less experience may be considered.
• Experience in leading proof of concept and/or registrational clinical trials, including protocol design, managing study start-up, directing, and guiding study team execution, data cleaning, medical monitoring/review, database locks.
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidate products is required.
• A strong commitment to clinical research and the ability to work well within a team setting are essential.
• This role requires 4 days a week on-site in Tarrytown, NY, Cambridge, MA, or Warren, NJ

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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)