The Medical Director functions as clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), under leadership of Program Lead Medical Director (Program Lead MD) or Sr. Medical Director. The Medical Director, Hematology Clinical Sciencesprovides clinical leadership and responsibility 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 communication and publications.The Medical Director 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. The Director ensures timely execution of assigned clinical deliverables within approved budget and supports Program Lead MD (and/or Sr. 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. The Director supports Program Lead MD (and/or Sr. MD) in ensuring overall safety of the compound in collaboration with the Safety Lead for the assigned program.The Medical Director contributes to CRF's, outsourcing specifications, data monitoring and validation plans, analysis plan for all trials to ensure consistency within the program and 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 (and/or Sr. MD). The Director 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, and serves occasionally as member for GCD training programs, author or reviewer for clinical SOPs. The Director may contribute to GCD strategy by serving on taskforces or other panels.
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