• Job Description

  Req#: R21984

  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.

  General Description:

  • Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations.

  Essential Functions of the job:

  • Demonstrates proficiency of skills required to conduct SSU activities from site identification through activation
  • Provide country-specific SSU expertise to project teams
  • Assignment as SSU Lead and back-up support as needed for direct or functional reports’ studies.
  • Competent in communication and influencing skills to ensure timely follow-up, issue resolution, and report updates
  • Support in management and maintenance of SSU resources (i.e., SSU Toolbox (Americas))
  • Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
  • Site Feasibility
    • Skilled in engaging sites during feasibility to efficiently execute CDAs and collect key information to support with site identification and selection; Liaise with internal stakeholders (i.e., CRAs, FMDs, CSMs) as needed.
    • Build knowledge in therapeutic area and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI.
  • Site Start-Up
    • Skilled in driving kick-off and completion of tasks from selection through activation.
    • Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
  • ICF/Submissions
    • Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
    • Skilled in document preparation and submission to central IRB to ensure timely reviews.
  • Ensure collection and review of essential documents
  • Ensure completion of SSU data entry in CTMS
  • Support in the facilitation of SSU Forum discussions
  • Support in the development of local workflows to streamline output and deliverables
  • Manage resource allocations and support in resource forecasting activities.
  • Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America
  • Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals

  Supervisory Responsibilities:

  Functional management – FSP

  Onboard new hires; ensure ongoing training compliance.

  Conduct regular 1:1s to assess workload, provide guidance, mentor and develop team.

  Participate in regular meetings with FSP leadership team.

  Meet with FSP line manager(s) to ensure timely feedback.

  Computer Skills: Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams

  Other Qualifications:

  • Knowledge in the execution of clinical trials, understanding of ICH/GCP
  • Effective prioritization of tasks in the achievement of goals
  • Strong written and verbal communication skills
  • Highly organized
  • Diligence in follow through
  • Functional Service Provider model knowledge and/or experience
  • Mentoring and training team members

  Travel: Up to 10%

  BeiGene Global Competencies

  When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

  Salary Range: $92,900.00 - $127,900.00 annually

  BeiGene 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. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

  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, 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.

• About the company

  BeiGene is a biotechnology company that specializes in the development of drugs for cancer treatment.

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