Medical Director, Clinical Development, Hematology

About This Role

This Medical Director will provide clinical leadership for the Hematology Oncology program, driving the execution of clinical deliverables and ensuring timely completion within budget. The role involves managing operational aspects of clinical programs, interacting with various stakeholders, and contributing to regulatory documents and clinical trial components.

Responsibilities

• Manage all operational aspects and drive execution of the clinical program section in partnership with global line functions, Clinical Scientist, and Clinical Operations associates
• Ensure timely execution of assigned clinical deliverables within approved budget
• Support Program Lead MD and lead interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, advisory boards, patient advocacy groups) and internal stakeholders
• Support Program Lead MD in ensuring overall safety of the compound in collaboration with the Safety Lead for the assigned program
• Contribute to CRFs, outsourcing specifications, data monitoring and validation plans, and analysis plans for all trials to ensure consistency within the program
• Contribute to/lead 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
• Ensure career development of GCD colleagues through active participation in performance management and talent planning processes, provide on-boarding, training, and mentoring support
• Serve as member for GCD training programs, author or reviewer for clinical SOPs, and contribute to GCD strategy by serving on taskforces or other panels

Requirements

• M.D. degree
• 0-4 years clinical research or drug development experience in industry (Phases 1-4)
• Strong management skills
• Interpersonal, communication, negotiation, and problem-solving skills
• Considerable organization awareness and experience working cross functionally
• Medical/scientific expertise in the disease area of assigned program
• Understanding of global regulatory environment (key regulatory agencies and approval processes)
• Strong understanding of operational aspects of all phases of clinical trial conduct

Qualifications

• M.D. preferably with clinical training in a relevant disease area
• 0-4 years' experience in clinical research or drug development in an industry environment spanning clinical activities in Phases 1 through 4

Nice to Have

• Clinical training in a relevant disease area (Hematology Oncology)

Benefits