Senior Medical Director, Clinical Development, Hematology Oncology

About the role

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.

Responsibilities

• 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 safety of the compound in collaboration with the Safety Lead for the assigned 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
• A strong understanding of the global regulatory environment including key regulatory agencies and approval processes
• A thorough understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

Qualifications

• People Management experience preferred but not required.

Skills

• Strong communication and interpersonal skills
• Ability to manage multiple projects simultaneously
• Experience with regulatory submissions and compliance

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 here.

Pay

$333,300.00 - $450,900.00 annually

Schedule

4 days a week on-site