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Manager, Biomarker Operations

Company: BeiGene
Location: Topeka
Posted on: September 19, 2022

Job Description:

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:The Manager, Biomarker Operations may be responsible for managing a small team and the following core responsibilities; manage central and biomarker testing labs, Manage biomarker related timeline, budget and quality for clinical trials, Execute biomarker strategy, Manage IVD partners for CDx studies, provide training and coaching to junior team members.This role will report into the Director, Clinical Biomarker Operations.Key Responsibilities:

  • Work closely with Clinical Operations and Translational Medicine to coordinate and manage the sample collection (tissue/blood) for on-going and planned clinical trials that have this component in their design (both USA and China-based teams)
  • Coordinate biospecimen banking procedures at BeiGene
  • Manage central lab and biomarker testing lab vendors including kit preparation, sample collection procedures, shipping requirements, data collection/reporting
  • Manage contracts with labs, academic institutions or bio-banks BeiGene is collaborating
  • Ensure/verify that collaborators (labs, institutions, bio- banks) have appropriate documentation, process, and procedures in place to ensure samples collected (prospective or retrospective)
  • Manage biomarker related budget
  • Ensure samples are analyzed tracked/stored
  • Review ICFs for sample/tissue collection
  • Ensure and review collaborators study files (the protocol and any amendments, correspondence with the IRB and BeiGene, and other study-related documents).
  • Manage retrieval of samples from tissue repositories/participating centers
  • Coordinate with our Diagnostic Development partners
  • Accountable to support and translate the Biomarker strategy for BeiGene programs and help assure that activities are executed within the expected quality, scope, budget, and timelines.
  • Demonstrated presentation and organizational skills.Experience
    • BS Degree with Minimum of 5 plus years of overall experience and success within other biotech/pharmaceutical companies, with three or more years in biomarker areas or an MS with 4 plus years of overall experience and success within other biotech/pharmaceutical companies, with three or more years in biomarker areas is required.
    • Experience in developing Informed Consent Forms for biospecimen acquisition is required.
    • Development of lab manuals and clinical trial protocol language is required.
    • A working knowledge of preanalytical biospecimen processing is required.
    • Knowledge of GLP/GCP framework is desired.
    • Knowledge of oncology drug development is preferred.
    • Team player with demonstrated success with cross-functional and global teams is preferred.
    • Experience with the development and support of related SOPs and ICFs is required.
    • Experience with partnerships and strategic alliances preferred.
    • Experience working in global environment preferred.
    • Prior management of budgets and timelines preferred.
    • Prior experience with vendor selection and management expected.Other Qualifications:
      • Supervisory experience preferredComputer Skills:
        • Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.Travel:
          • 0 5%Competencies:Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others.Adaptability Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.Project Management - Communicates changes and progress; Completes projects on time and budget.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.

Keywords: BeiGene, Topeka , Manager, Biomarker Operations, Executive , Topeka, Kansas

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