Senior Medical Director, Clinical Development, Hematology Oncology

Job Summary

The Senior Medical Director, Clinical Development provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program in Hematology Oncology with minimal supervision from Program Lead MD. Clinical deliverables may include individual protocols consistent with the Clinical Development Plans (CDP); clinical components of regulatory documents/registration dossier and brand related medical information, clinical communications and publications.

Location

Tarrytown, NY or Warren, NJ

Work Model/Flexibility

4 days a week on-site

Travel Percentage

10% to relevant congresses/conferences

Discover Your Role

• Manages all operational aspects and drives execution of clinical programs in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates to ensure timely execution of assigned clinical deliverables within approved budget.
• Leads interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups), internal stakeholders (e.g., Research, Early Clinical Development, Medical Affairs, Marketing, HE&OR), and internal decision boards.
• Safeguards the overall safety of the compound in collaboration with the Safety Lead for the assigned program.
• Contributes to CRFs, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program.
• Develops clinical sections of program level regulatory documents such as Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions with minimal input from Program Lead MD.

Requirements

• M.D. degree, preferably with clinical training in a relevant disease area
• More than 4 years' demonstrated experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4
• Strong understanding of global regulatory environment including key regulatory agencies and approval processes
• Comprehensive understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

Preferred Qualifications

• People Management experience

Benefits

Includes 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 here.

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.

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