Senior Medical Director, Clinical Development, Classical Hematology

Regeneron Pharmaceuticals, Inc.; Village of Tarrytown (NY); On-site; USD 333,000 - 451,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) in Tarrytown, NY seeks a Senior Medical Director to lead our Classical Hematology program, focusing on Factor XI and Thrombosis. You will oversee clinical deliverables, drive regulatory filings, and manage interactions with regulators and key opinion leaders on a global scale.

The role requires an MD or equivalent with 4+ years of industry clinical research experience across Phases 1–4, and a strong understanding of regulatory processes.

Qualifications

• MD or equivalent medical degree with clinical development experience.
• 4+ years of clinical research in industry, across Phases 1–4.
• Strong understanding of global regulatory environment and trial operations.

Responsibilities

• Provide clinical leadership and responsibility for all clinical deliverables within an assigned section of a clinical program in Hematology/Oncology.
• Lead interactions with external stakeholders (regulatory authorities, KOLs, advisory boards, patient groups) and internal stakeholders.
• Ensure overall safety of the compound in collaboration with the Safety Lead for the assigned program.
• Lead development of clinical sections of program-level regulatory documents (IBs, briefing books, safety updates) and responses to Health Authority questions.

Skills

Clinical leadership

Program management

Regulatory interactions

Cross-functional collaboration

Budget management

Education

M.D. or equivalent medical degree

Job description

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 Classical Hematology team supporting our Factor XI, Thrombosis program.

In this role, you will provide clinical leadership and responsibility for all clinical deliverables within an assigned section of a clinical program in Hematology/Oncology, operating with minimal supervision from the Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plan (CDP), clinical components of regulatory documents and registration dossiers, brand-related medical information, and clinical communications and publications. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a significant difference for patients worldwide.

When & where

Location: Tarrytown, NY Travel: 10%, to relevant congresses and conferences

Discover your role

• Manage all operational aspects and drive execution of clinical programs, in partnership with global line functions, the assigned Clinical Scientist, and Clinical Operations associates, to ensure timely execution of assigned clinical deliverables within approved budget.
• Lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, Health Economics & Outcomes Research [HE&OR]), as well as internal decision boards.
• Ensure the overall safety of the compound in collaboration with the Safety Lead for the assigned program.
• Lead development of clinical sections of program-level regulatory documents, such as Investigators' Brochures, briefing books, safety updates, and IND/NDA (Investigational New Drug/New Drug Application) submission documents, and lead responses to Health Authority questions.

This role requires

• A M.D. or equivalent medical degree (e.g., D.O., MBBS), preferably with specialized clinical training in a relevant disease area such as Classical Hematology or Cardiology Significant demonstrated experience of 4+ years in clinical research within an industry environment, spanning clinical activities across Phases 1 through 4.
• Strong understanding of the global regulatory environment, including key regulatory agencies and approval processes.
• Strong understanding of the operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out).
• People management experience preferred but not required.

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. Salary Range (annually) $333,300.00 - $450,900.00

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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site 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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA‑approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.