Senior Director, Clinical Development

Beigene, Ltd. Apac Ridgefield Park , NJ 07660

Posted 2 months ago

BeiGene 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 Senior Director, Clinical Science 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.

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 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, PharmD. or PhD. within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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Senior Director, Clinical Development

Beigene, Ltd. Apac