Senior Manager, Clinical Science

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne 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.

General Description:

The Senior Manager – Clinical Science will support BeiGene Clinical and Medical assets in the successful execution of clinical development programs and deliverables working in partnership across the organization (clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research), with external vendors, and with external academicians and collaboration partners.

The Senior Manager will support clinical program activities and help assure they are executed within expected scope, budget and timelines.

Key Responsibilities:

• Facilitate the generation of, 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), Developmental Safety Update Reports, Health Authority briefing documents, Orphan Drug applications, and annual reports

  • Risks / benefits analysis for applicable documents

• Partner with Clinical Operations and other functional areas for the successful implementation and execution of clinical studies

• Support Clinical Operations in clinical trial budget planning and management

• Contribute to or perform therapeutic area/indication research and competitor analysis

• Review, query, and analyze clinical trial data

• Interpret, and present clinical trial data both internally and externally

• Provide scientific support throughout conduct of a clinical trial; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs

• Create clinical study or program-related slide decks for internal and external use

• Develop, track, execute and report on goals and objectives

• Be accountable for compliant business practices

Managerial Responsibilities:  

None

Required Competencies

Clinical Development Expertise

• Demonstrates basic knowledge of clinical study design, including familiarity with Phase 1-4 trial activities and standards, and GCP and ICH guidelines

• Able to complete basic data review and analysis activities
   

Problem Solving

• Analyzes, evaluates, and solves problems accurately in own area of work
   

Communications

• Observes and listens for main points in communications from others, suspends bias and asks clarifying questions and/or summarizes to confirm understanding

• Communicates ideas and intentions in a clear, timely, practical manner

• Ensures that important information is consistently shared with managers, peers and business partners in a timely manner to enable effective decision-making and/or execution

• Selects most appropriate communication method for optimal outcome (e.g. uses phone/in- person vs email)
   

Teamwork

• Fosters mutually beneficial working relationships

• Demonstrates ability and willingness to actively participate and contribute to group efforts

• Develops and maintains strong working relationships with people across the department and in cross-functional teams

• In a team environment, demonstrates eagerness to support others’ efforts

Qualifications:

• PharmD; or PhD within a clinical and/or scientific profession; MD (or equivalent)

• Minimum of 3+ years relevant experience; clinical trials and industry experience preferred
   

Travel: 

Approximately 25% of work may involve domestic and/or international travel

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competenci