Senior Medical Director, Clinical Development, Ophthalmology

BioSpace; Village of Tarrytown (NY); Presencial; USD 333.000 - 451.000; Jornada completa

Descripción de la vacante

Regeneron is seeking a Senior Medical Director to join the Ophthalmology Therapeutic Area, guiding clinical development from first-in-human through registration-enabling studies. You will lead clinical strategy, regulatory submissions, and cross-functional collaboration with internal and external stakeholders.

Location options include Tarrytown, NY; Cambridge, MA; or Warren, NJ. 10% travel to conferences and a focus on patient safety and high-quality clinical documentation.

Formación

• MD or equivalent medical degree, board certification or eligibility in Ophthalmology.
• Minimum of 4 years of industry experience in early or late clinical development.
• Experience leading proof-of-concept and/or registrational clinical trials, including protocol design and study execution.
• Solid knowledge of global regulatory requirements (ICH) for pharmaceutical development.

Responsabilidades

• Act as medical expert and leader in interactions with external stakeholders, internal stakeholders, and decision boards.
• Develop innovative clinical strategies to shorten development cycles amid an evolving regulatory landscape.
• Design efficient, robust Phase 1, 2, and 3 programs.
• Partner with research and discovery teams to inform the next generation of targets in the field.
• Safeguard patient safety in clinical studies and support signal detection from post-marketing surveillance.
• Ensure the quality of clinical documents, including investigator brochures, protocols, study reports, and regulatory submission materials.
• Draft responses to regulatory agency questions and prepare regulatory submission documents.
• Build consensus and drive sound decision-making across dynamic, matrixed clinical teams.

Conocimientos

Clinical leadership

Trial design

Regulatory submissions

Cross-functional leadership

Educación

MD or equivalent medical degree

Descripción del empleo

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Medical Director to join our Ophthalmology Therapeutic Area, supporting clinical development programs from first-in-human through registration-enabling studies. In this role, you will serve as scientific and medical lead for clinical team(s), guiding development strategy and regulatory submissions while collaborating with Internal Medicine leadership, executive leadership, development partners, and global regulatory agencies. This role reports to the Vice President, Ophthalmology Therapeutic Area Lead.

When & Where

Location: Tarrytown, NY; Cambridge, MA; or Warren, NJ
Travel: 10% to relevant conferences

Discover Your Role

• Act as medical expert and leader in interactions with external stakeholders, internal stakeholders, and decision boards
• Develop innovative clinical strategies to shorten development cycles amid an evolving regulatory landscape
• Design efficient, robust Phase 1, 2, and 3 programs
• Partner with research and discovery teams to inform the next generation of targets in the field
• Safeguard patient safety in clinical studies and support signal detection from post-marketing surveillance
• Ensure the quality of clinical documents, including investigator brochures, protocols, study reports, and regulatory submission materials
• Draft responses to regulatory agency questions and prepare regulatory submission documents
• Build consensus and drive sound decision-making across dynamic, matrixed clinical teams

This Role Requires

• MD or equivalent medical degree, with board certification or eligibility in Ophthalmology
• Minimum of 4 years of industry experience in early or late clinical development (candidates with strong academic backgrounds and less experience may be considered)
• Experience leading proof-of-concept and/or registrational clinical trials, including protocol design and study execution
• Solid knowledge of global regulatory requirements (ICH) for pharmaceutical development
• #MDJobs, #MDJOBSCD, #GDTherapeuticJobs, #Ophthalmology

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.

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)
$333,300.00 - $450,900.00