AbbVie Principal Research Scientist I, Translational Oncology, Clinical Biomarker Lead in Sunnyvale, California
Principal Research Scientist I, Translational Oncology, Clinical Biomarker Lead
USA, California, Sunnyvale
Research & Development
General Position Summary/Purpose:
Responsible for conception and implementation of overall biomarker strategy and development plans to support early stage clinical programs in AbbVie’s oncology pipeline and portfolio. Directs pharmacodynamics, mechanisms of action/resistance, patient selection, safety and other clinically relevant biomarker studies through external CRO and internal efforts. Collaborates closely with Discovery, Clinical Science, Data Science, Clinical Operation, and Regulatory Departments to deliver biomarker results/reports to internal stakeholders and external regulatory agencies. Ensures that overall budgets, schedules, and performance standards are attained.
Accountable for the operational execution of biomarker strategy in oncology clinical studies, in compliance with AbbVie’s processes and regulatory requirements.
Key Accountabilities/Core Job Responsibilities:
Works in the Translational Oncology Department to develop, establish, and lead efforts aimed at exploring novel biomarkers with association to clinical endpoints in early stage oncology studies.
Leads cross-functional Translational Oncology Working Group to drive biomarker analyzes using a deep biological understanding of clinical genetics, cancer biology or immuno-oncology.
Undertakes cross-functional engagement with Clinical Science and Clinical Operations for implementation of biomarker assays in the clinic.
Manages relationships with external analytical labs, provide input into trial-specific agreements and perform technical assessment of labs involved in biomarker sample analysis. Coordinates between CRO Assay Development group and clinical team, when necessary.
Provides input on biomarker-related sections in clinical study-related and regulatory documents (such as Clinical protocol, INDs, IBs, etc.).
Contribute to the biomarker assessments in clinical protocols to develop the central and reference laboratory components.
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.
BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of experience in area or scientific area of discipline
Demonstrated ability to function as a principle investigator, generating original technical ideas and research or development biomarker strategies.
Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals.
Ability to multitask and work within timelines.
Experienced and demonstrated success as primary author of publications, presentations, regulatory documents and/or primary inventor of patents.
Demonstrated scientific communication and presentation skills by presenting at leading scientific conferences.
Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
Proven record of success in leading clinical biomarker studies in Biopharmaceutical companies, preferentially in oncology settings.
Significant Work Activities and Conditions: N/A
Job Type: Experienced
Job Level Code: M