Sr. Medical Director – Clinical Development – Hematology

Sr. Medical Director – Clinical Development – Hematology

Requirements

• M.D. preferably with clinical training in a relevant disease area
• More than 5 years’ experience in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases 1 through 4
• People management experience in a matrixed environment
• Strong understanding of operational aspects of all phases of clinical trial conduct (start-up, conduct, close-out)

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.

Preferred Qualifications

• Strong management, interpersonal, communication, negotiation, and problem-solving skills
• Considerable organization awareness, including significant experience working cross functionally
• Medical/scientific expertise in the disease area of assigned program
• Understanding of global regulatory environment including key regulatory agencies and approval processes