Senior Medical Director, Clinical Development, Factor XI

Regeneron Pharmaceuticals • Warren, MI

10d • Onsite

About The Position

The Senior Medical Director, Clinical Development provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program, Factor XI, 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. A day in the life may include the following responsibilities: Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates. Ensures timely execution of assigned clinical deliverables within approved budget. Supports Program Lead MD and frequently lead 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. Supports Program Lead MD in ensuring overall safety of the compound in collaboration with the Safety Lead for the assigned program. Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program. Contributes/Leads development of 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. Ensures career development of GCD colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of GCST members as appropriate. Serves frequently as member for GCD training programs, author or reviewer for clinical SOPs. May contribute to GCD strategy by serving on taskforces or other panels. This job may be for you if you: Want to impact patients by developing new and innovative therapies Have strong management, interpersonal, communication, negotiation, and problem-solving skills Considerable organization awareness, including significant experience working cross functionally Have medical/scientific expertise in the disease area of assigned program Understand global regulatory environment including key regulatory agencies and approval processes Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

Requirements

• M.D. preferably with clinical training in a relevant disease area.
• More than 4 years' experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4 is required.
• Want to impact patients by developing new and innovative therapies
• Have strong management, interpersonal, communication, negotiation, and problem-solving skills
• Considerable organization awareness, including significant experience working cross functionally
• Have medical/scientific expertise in the disease area of assigned program
• Understand global regulatory environment including key regulatory agencies and approval processes
• Have a strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

Nice To Haves

• People Management experience preferred but not required.

Responsibilities

• Manages all operational aspects and drives execution of the section of the clinical program in partnership with global line functions, assigned Clinical Scientist and Clinical Operations associates.
• Ensures timely execution of assigned clinical deliverables within approved budget.
• Supports Program Lead MD and frequently lead 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.
• Supports Program Lead MD in ensuring overall safety of the compound in collaboration with the Safety Lead for the assigned program.
• Contributes to CRF’s, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program.
• Contributes/Leads development of 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.
• Ensures career development of GCD colleagues through active participation in the performance management and talent planning processes.
• Provides on-boarding, training, and mentoring support and contributes to the performance evaluation of GCST members as appropriate.
• Serves frequently as member for GCD training programs, author or reviewer for clinical SOPs.
• May contribute to GCD strategy by serving on taskforces or other panels.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees