Medical Director, Hematology

Essential Functions Of The Job

• Facilitate generation of, author, update, and/or review key documents, including, but not limited to:
• Protocol concepts, synopses, protocols, and amendments
• Informed consent documents
• Investigator Brochures
• Clinical study reports
• Abstracts, posters and manuscripts
• Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
• Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
• Risks / benefits analysis for applicable documents
• Clinical Development Plans
• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies
• Provide scientific expertise for selection of investigator and vendors
• Train BeOne colleagues, study site staff on the therapeutic area, molecule, and/or clinical protocol
• Provide scientific and medical support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities
• Review, query, and analyze clinical trial data
• Interpret, and present clinical trial data both internally and externally
• Represent a clinical study or development program on one or more teams or sub teams
• Create clinical study or program-related slide decks for internal and external use
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings
• Contribute to or perform therapeutic area/indication research and competitor analysis
• Identify continuous process improvement opportunities.
• Identify incremental organizational resource needs – staff, budget, and systems
• Develop, track, execute and report on goals and objectives
• Support budget planning and management

Qualifications

• MD (or equivalent medical degree); board certification or eligibility in relevant therapeutic area (e.g., oncology, hematology)
• Clinical training with experience in drug development or clinical research, ideally across Phases I–IIIStrong understanding of clinical trial design, GCP and regulatory environment for submissions (IND, CTA, NDA, BLA)
• Demonstrated safety oversight skills, familiarity with DSURs, PSURs, and safety committees
• Excellent communication skills, capable of engaging internal teams, external partners, and regulators.

Preferred

• Proven track record in therapeutic area development (hematology or oncology)
• Experience or familiar with translational medicine, PK/PD data integration, or biomarker strategies.
• Prior involvement with Life Cycle Management and commercial interfacing
• Global clinical trial experience across multiple geographies

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Communicates with Clarity
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Pay

Salary Range: $249,800.00 - $309,800.00 annually