[Hiring] Director, Clinical Development @BeiGene

Role Description

The Director, Clinical Development will support BeOne 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 in 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
• 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, NDAs, 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.

Qualifications

• MD, DO, PhD, PharmD or international equivalent degree required.

Requirements

• 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.

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• All employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.

Company Description

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor.

We are proud to be an equal opportunity employer. BeOne 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. All employment is decided on the basis of qualifications, merit, and business need.

In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].