BeiGene
Senior Director Clinical Development, Solid Tumors
BeiGene, Emeryville, California, United States, 94608
The Senior Director, Clinical Development, Solid Tumors 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 Vice President, Clinical Development.
As a leader in the organization, the incumbent will be involved 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.
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 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
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.
Required Experience:
8 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies
Advanced degree (MD or MD equivalent) with subspecialty training in oncology (preferred)
Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist role
Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology
Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing
High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
Knowledge of GCP and ICH Guidelines
Flexibility to work with colleagues in a global setting
Able to engage in work-related travel approximately 25%
Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred
Experience with the development and support of related SOPs and policies is expected
Knowledge of industry standard Clinical Development IT solutions 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.
As a leader in the organization, the incumbent will be involved 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.
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 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
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.
Required Experience:
8 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies
Advanced degree (MD or MD equivalent) with subspecialty training in oncology (preferred)
Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical scientist role
Clinical oncology experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology
Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing
High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills
Knowledge of GCP and ICH Guidelines
Flexibility to work with colleagues in a global setting
Able to engage in work-related travel approximately 25%
Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred
Experience with the development and support of related SOPs and policies is expected
Knowledge of industry standard Clinical Development IT solutions 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.