Remote (Global) Full-time

BeOne is hiring a Director, Clinical Science

About the Role

BeOne is looking for a Director, Clinical Science to support our clinical and medical assets by executing development programs and deliverables. You'll jointly develop clinical program strategy and help assure activities are executed within expected scope, scientific integrity, and timelines. A key part of this role involves helping to establish and grow our clinical research functions to build best-in-class global capabilities.

What You'll Do

  • Facilitate generation, author, update, and/or review key documents including protocol concepts, synopses, protocols, amendments, informed consent documents, Investigator Brochures, clinical study reports, abstracts, posters, manuscripts, and clinical sections of regulatory documents.
  • Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.
  • Provide scientific expertise for selection of investigators 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.
  • Work across multiple time zones.

What We're Looking For

  • 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).
  • Minimum of 10+ 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 (from start up to study report).
  • Clinical oncology experience.
  • 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%.
  • Experience with the development and support of related SOPs and policies.
  • Knowledge of industry standard Clinical Development IT solutions.

Nice to Have

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

Team & Environment

May report to the Executive Director, Clinical Science.

Benefits & Compensation

  • Compensation: $178,600.00 - $238,600.00 annually + equity: All employees are eligible for discretionary equity awards.
  • Medical, Dental, Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness
  • All employees are eligible for discretionary equity awards.
  • Voluntary participation in the Employee Stock Purchase Plan.
  • Non-Commercial roles are eligible to participate in the annual bonus plan.
  • Commercial roles are eligible to participate in an incentive compensation plan.

Work Mode

This is a global role.

BeOne is proud to be an equal opportunity employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law.

Required Skills
Clinical ScienceClinical DevelopmentClinical Trial DesignProtocol DevelopmentRegulatory SubmissionsCross-functional LeadershipStrategic PlanningData InterpretationStakeholder ManagementProject ManagementTeam LeadershipMedical WritingFDA/EMA Guidelines
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About company
BeOne

BeOne is a company passionate about fighting cancer.

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Posted 3 months ago