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The Senior Director, Clinical I/O Development will support BeiGene Clinical and Medical 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 VP of Clinical Development. As a leader in the organization, the incumbent will be accountable to jointly develop clinical program strategy 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 leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research.

Key roles and Responsibilities:

• Key contributor in Clinical development strategy, planning and leading presentations to various internal governance committees

• Provides leadership and clinical oversight across all assigned studies and programs (up to 2 programs in early development and up to 2 studies in late development)

• Seamless transition of drug candidates from research to early clinical development

• Effective integration of in-licensed drug candidates into early clinical development portfolio

• Effective development of early asset's according to stringent criteria and applied across all early programs

• Effective transition assets' programs from early to late clinical development

• Engagement with KOL's and Collaborators

• Training of clinical team and other functional teams, as appropriate

• Assessment of Investigator Initiated & Collaborator Research program

Essential Functions of the job:

• Facilitate generation of, author, update, and/or review key documents

• 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 BeiGene colleagues, CRO staff, and 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, 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

• Understands competitive clinical development landscape, contributes to or perform therapeutic area/indication competitor research and adjusts strategy accordingly

• Identifies strategic and incremental organizational resource needs re: People, Process and Technology

• 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 and Experience Required:

• MD or DO with a minimum of 6+ years of experience and success within other biotech/pharmaceutical companies or equivalent experience in academia, with 5 or more years in clinical development areas, is required

• Professional knowledge and skills working in oncology therapeutics is required

• Strategic leader with demonstrated success building, managing and developing individuals and teams

• Working knowledge of applicable International Compliance guidelines and regulations is expected

• Experience working in global environment is required

• Experience with the development and support of related SOP's and policies is expected

• Experience with partnerships and strategic alliances is expected

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.