What are the responsibilities and job description for the Senior Medical Director, Hematology position at BeiGene?
BeiGene Senior Medical Director, Hematology in Emeryville, California
General Description :
The Senior Medical Director, Hematology will support BeiGene Clinical and Medical Hematology assets by successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. The candidate will report to the Vice President, Global Clinical Development.
As a leader in the organization, the incumbent will be involved in clinical program strategy and helping to assure that activities are executed within expected scope, budget, and timelines. The incumbent will play a key role in 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 leadership, biometrics, clinical operations, safety / pharmacovigilance, regulatory, molecular diagnostics, and translational research.
Essential Functions of the job :
- Facilitate generation of, author, update, and / or review key documents, including, but not limited to : 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.
- Conduct risks / benefits analysis for applicable documents.
- Develop 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 BeiGene colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and / or clinical protocol.
- Provide scientific and medical support throughout the conduct of a clinical trial; respond to clinical questions from sites, IRBs / IECs, Health Authorities, and CROs.
- 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.
Education Required :
Required Experience :
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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