Senior Medical Director, Clinical Development, Hematology/Oncology
When & where:- Location: Tarrytown, NY or Warren, NJ
- Work model/flexibility: 4 days a week on-site
- Travel percentage: Approximately 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 clinical training in a relevant disease area such as Hematology or Oncology.
- 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.
#MDJobs #MDJobsCD #GDTherapeuticJobs #HematologyDoes 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.
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 on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$333,300.00 - $450,900.00
