The Director, Clinical 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.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.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 o Informed consent documents;
Investigator Brochures o Clinical study reports;
Abstracts, posters and manuscripts o 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 CRO’s
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 subteams.
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 Education:
MD or DO or international equivalent degree.
Required Experience:
5 plus years of experience and success within other biotech/pharmaceutical companies.
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 development 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.
