Manager, Clinical Biomarker Operations
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, Repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Turning Point Therapeutics is driven to develop therapies that mark a turning point for patients in their cancer treatment.
Oncology is a key therapeutic area for TP Therapeutics, Inc. TP is expanding its oncology team focused on the discovery and development of novel oncology therapies. This position is based in San Diego, CA. The candidate will report to the Executive Director of CDx and Biomarker Operation.
As a member of the Biomarker Operations team, the incumbent 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 scientific expertise in technology platforms relevant to biomarker testing and development, as represented by publications.
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.
Essential Duties and Job Functions:
- 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 the 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 sample collection.
- Develop and update 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, invoice approval, and other study-related documents).
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 2-5 years of experience and success within other biotech/pharmaceutical companies, with experience 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.
- 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.
- 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 a global environment preferred.
- Prior experience with vendor selection and management expected.
Capabilities and Competencies
- Excellent people skills with the ability to interface with multiple cross-functional teams and groups including Clinical Operations, clinical sites, and CROs.
- Ability to build working relations throughout the organization and with business partners to achieve business goals.
- Excellent and proactive verbal and written communication as well as judgment and problem-solving skills.
- Strong time management and information-organizing skills and ability to prioritize multiple tasks within multiple projects.
- Strong project and people management skills. Task- and detail-oriented. Ability to manage multiple projects in a fast-paced environment.
- Values-based collaborator – respectful, accountable, and collaborative. Appreciation of diversity and multiculturalism.
- Knowledge of GCPs for global compliance.
- Scientific and technical expert on biomarkers.
- 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.