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-III
Strong 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
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity
Benefits
Health insurance
Additional Information
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
The Medical Director, Hematology will support BeOne clinical assets and pipeline by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. As a leader in the organization, the incumbent will be accountable to assess and execute clinical programs and help assure that activities are executed within expected scope, budget and timelines. The incumbent will play a key role the establishment and growth of Clinical Research functions to assure best-in-class global capabilities and execution. Specifically, the incumbent will work closely with colleagues in clinical development, program management, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research and other functions.
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
Build strong relationships with internal experts
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
Be accountable for compliant business practices
Beigene · Remote