Principal Scientist, Translational Medicine
General Position Summary/Purpose: Responsible for implementation of overall biomarker strategy and development plans to support solid tumors and hematology/oncology clinical studies. Directs and performs pharmacodynamic marker, flow cytometry, immunohistochemistry and next-generation sequencing assays through external CRO and/or internal efforts. Collaborates closely with Clinical Science, Biometrics, Clinical Operation, and Regulatory Departments to deliver biomarker results/reports to internal stakeholders and external agencies. Ensures that overall budgets, schedules, and performance standards are attained. Accountable for the timely operational execution of biomarker assessments in solid tumors and hematology/oncology protocols, in compliance with Pharmacyclics processes and regulatory requirements. Key Accountabilities/Core Job Responsibilities:
- Works in the Discovery Organization, develops, establishes, and leads efforts aimed at discovery of novel biomarkers with association to clinical endpoints in oncology studies.
- Collaborates with bioinformatics team to drive biomarker analyzes using a deep understanding of clinical genetics, immune-oncology and the role of tumor microenvironment.
- Undertakes cross-functional engagement with Clinical Science and Clinical Operations for implementation of biomarker assays in the clinic.
- Provides critical review of Investigator Sponsored Trials (IST) or Co-Operative group studies such as Cancer Therapy Evaluation Program (CTEP) proposals with translational medicine focus feedbacks to study review committees.
- Provides input on biomarker-related sections in clinical study-related and regulatory documents (such as Clinical protocol, INDs, IBs, etc.).
- Develops and manages Translational Medicine/Biomarker publication strategy.
- Participates in reviews and provides recommendations for business development opportunities.
- Ensures that biomarker samples selection, data transfer, analyzes and reporting are performed in accordance to the study protocol and in compliance with regulatory requirements.
- Participates in drafting of clinical study-related and regulatory documents, such as INDs, ICFs, IBs, Clinical Study Reports, ad hoc analyses, etc.
- Proven record of success in leading clinical biomarker studies in pharmaceutical or biotechnology companies , preferentially in solid tumor settings.
- Expertise in frequently used clinical biomarker assay and a background in studying the role of infiltrating immune cells in solid tumors.
- Understanding of clinical trial designs and clinical operations.
- Excellent organizational skills, communication skills between research, clinical and biometrics staff.
- Deep understanding and expertise in cancer biology.
- PhD in biological science or related field with 8 years of relevant Translational Medicine/Biomarker work experienced in in an industry setting
- Experience in drug development in a pharmaceutical or biotechnology company with significant expertise in mid to late stages of clinical development is preferred.
- Small-molecule kinase inhibitor R & D experience preferred.
- Deep understanding of immune-oncology and tumor micro-environment in solid tumors is preferred.