As a member of the Biomarker Operations team, the Clinical Biomarkers Operations Associate will be accountable to establish operational processes for the appropriate collection of biospecimens from clinical trials and vendors to support biomarker testing and companion diagnostic development. The individual will assist in developing biomarker plans to support pre-clinical and clinical programs, including the strategy and goals, experimental validation, timelines and budget. The incumbent is expected to have deep scientific expertise in technology platforms relevant to biomarker testing and development, as represented by publications. This position reports to the Vice President, CDx & Biomarker Development.
The successful candidate will have the opportunity to work closely with Clinical Operations, Translational Medicine, CROs and clinical sites to coordinate and manage the sample collection (tissue/blood) for on-going and planned clinical trials.
- Biomarker (including PK, PD, prognostic and predictive markers) sample logistics, vendor and data management.
- Track the collection and shipment of clinical samples from the clinical site to biobanks or 3rd party laboratories for testing; working closely with Clinical Operations, CROs and Translational Medicine to ensure all samples are collected, shipped and received according to schedule.
- Work closely with Clinical Operations, CROs and/or clinical sites to resolve sample related issues in a timely manner.
- Manage retrieval of samples from tissue repositories/participating centers.
- Coordinate sample logistics and data transfers with Diagnostic Development partners.
- Manage kit preparation, sample collection procedures, shipping requirements, data collection/reporting.
- Ensure and verify that collaborators have appropriate documentation, processes, and procedures in place to ensure appropriate samples collection.
- Developing and updating current data transfer specifications by gathering input from biomarker leads, data management and data scientists to ensure consistent data transfers.
- Ensure vendors keep to the schedule of data transfers and the data format is consistent with internal infrastructure.
- Clear understanding of programs’ clinical biomarker plan, which enables the review of laboratory manuals, informed consents, analytical plans, and SOWs.
- Ensure review of study files (the protocol and any amendments, ICFs for sample/tissue collection, correspondence with the IRB, and other study-related documents).
- 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 2-5 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 and clinical database is desired.
- Knowledge of oncology drug development 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 experience with vendor selection and management expected.
- Excellent people skills with ability to interface with multiple cross-functional teams and groups including Clinical Operations, clinical sites and CROs.
- Excellent and proactive verbal and written communication as well as judgment and problem-solving skills.
- Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.
EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
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