BeiGene Senior Biomarker Operations Specialist in Topeka, Kansas
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.
The Senior Biomarkers Operations Specialist will manage central and biomarker testing labs, manage biomarker related timeline, budget and quality for clinical trials and execute biomarker strategy.
Essential Functions of the job:
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 kit preparation, sample collection procedures, shipping requirements, data collection/reporting
Manage contracts with CROs, academic institutions or tissue banks BeiGene is collaborating with regarding tissue studies
Ensure/verify that collaborators (institutions, tissue banks) have appropriate documentation, process, and procedures in place to ensure samples collected (prospective or retrospective)
Manage budget negotiations
Ensure samples are de-labeled (de-identified) and tracked/stored
Assist with protocol design/review
Manage Final Report generation, review, and finalization
Manage contract /MTA (Material Transfer Agreement) generation and negotiation
Developing ICFs for sample/tissue collection
Review ICFs of retrospective studies
Ensure and review collaborators study files (the protocol and any amendments, correspondence with the IRB, and other study-related documents).
Manage retrieval of samples from tissue repositories/participating centers
Coordinate with our Diagnostic Development partners
- BA/BS Degree or above, preferably in the life sciences
Minimum of 5 - 7 years of 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 ICF’s 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.
Strong organizational skills, ability to prioritize and multi-task
Excellent verbal and written communication skills
Strong project and people management skills
Values based collaborator – respectful, accountable and collaborative.
Ability to relate and work with a wide range of people to achieve results.
Experience with contract and budget development, negotiation, and management; vendor management; and data and sample management
Protocol development is a plus
Knowledge of GCPs for global compliance
Experience in working in cross-functional team environment
Positive, flexible, self-starter, who thrives under pressure
Excellent judgment and problem solving skills
Scientific and technical expert on biomarkers.
Successful and superior influencing skills across all levels of the organization and external collaborators.
Appreciation of diversity and multiculturalism.
Strategic and creative thinker.
Ability to build working relations throughout the organization and with business partners to achieve business goals.
Strong time management and organizational skills.
Ability to manage multiple projects in a fast paced environment.
Supervisory Responsibilities: N/A
- Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.
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.