The Biomarker Operations Manager will support BeiGene’s early and late stage pipeline programs by the successful execution of deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners. The candidate will report to the Senior Director of CDx and Biomarker Development.
As a leader of the Biomarker Operations team in the USA, the incumbent will be accountable to establish operational processes for the appropriate implementation of biospecimen collection procedures from clinical trials and vendors to support biomarker and companion diagnostic development. The individual will assist in developing biomarker plans to support the clinical and pre-clinical programs, including the strategy and goals, experimental validation, timelines and budget.
The incumbent is expected to have deep scientific expertise in platforms relevant to biomarker development, as represented by publications.
The key tasks for the Manager will include the following:
- 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 Clovis Oncology, and other study-related documents).
- Manage retrieval of samples from tissue repositories/participating centers
- Coordinate with our Diagnostic Development partners
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.
- Advanced degree within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
- 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.
Capabilities and Competencies
- 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.
- Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.
San Francisco Bay Area (Emmeryville or San Mateo)
The Manager will have the interpersonal skills required to communicate effectively with collaborators and development core team members (USA and China). This individual must be highly motivated and enjoy working in a fast paced, challenging matrix environment. Additionally, this role requires a flexibility relative to responsibilities, as BeiGene is a growing company and job scope/role will inevitably evolve as the company matures.