Sr Medical Director, Clinical Development, Hematology C5

Regeneron Pharmaceuticals•Tarrytown, NY

44d•Onsite

About The Position

The Senior Medical Director, Clinical Sciences, Hematology C5 provides clinical leadership and is responsible for all clinical deliverables within the assigned section of a clinical program 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. Maintains current understanding of the 1-2 primary projects, and disseminates with other team members new findings, conference themes Maintains 1-2 early development projects (preclinical) with close ties to research 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 and ability to assume new areas of expertise within hematology-oncology 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) In order to be considered for this position, you must have an M.D. preferably with clinical training in a relevant disease area. Basic or applied science background with at least 2 or more publications that indicate depth and academic leadership. 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. People Management experience is not required but would be a plus.

Requirements

M.D. preferably with clinical training in a relevant disease area
Basic or applied science background with at least 2 or more publications that indicate depth and academic leadership
More than 4 years' experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4
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 and ability to assume new areas of expertise within hematology-oncology
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

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.
Maintains current understanding of the 1-2 primary projects, and disseminates with other team members new findings, conference themes
Maintains 1-2 early development projects (preclinical) with close ties to research

Benefits

comprehensive benefits, which vary by location. In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!

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