Principal Research Scientist, Translational Oncology - Clinical Biomarkers

Job Description

**This position can sit out of the San Francisco Bay Area** We are seeking a highly motivated Principal Research Scientist with a proven track record of scientific accomplishments to join our growing Precision Medicine organization. The Translational Oncology group within Precision Medicine at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to further AbbVie’s innovative Oncology pipeline. The Clinical Biomarker lead is responsible for the design and implementation of overall biomarker strategy and development plans to support clinical programs in AbbVie’s oncology pipeline and portfolio. The scientist will lead translational scientific efforts across early and late development; first in human studies (FIH), registrational studies and lifecycle management. This role oversees pharmacodynamic, mechanism of action/resistance, patient selection, and other clinically relevant biomarker studies through external CRO and internal efforts. Through close collaborations with Discovery, Clinical Science, Data Science, Clinical Operation, and Regulatory Departments, the Clinical Biomarker lead delivers biomarker results/reports to internal stakeholders and external regulatory agencies. The role ensures that overall budgets, schedules, and performance standards are attained and is accountable for the execution of biomarker strategy in oncology clinical studies, in compliance with AbbVie’s processes and regulatory requirements. The key responsibilities will be:

• Works in the Translational Oncology Department within the Precision Medicine organization to develop, establish, and lead efforts aimed at exploring novel biomarkers with association to clinical endpoints in early and late stage oncology studies.
• Leads cross-functional Translational Oncology Working Group to drive biomarker analyses using a deep biological understanding of mechanisms of action, clinical genetics, and cancer biology.
• Undertakes cross-functional engagement with Clinical Science and Clinical Operations for implementation of biomarker analyses 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.
• Leads drafting of biomarker-related sections in clinical study-related and regulatory documents (such as clinical protocols, ICFs, INDs, IBs, clinical study reports, etc.).
• Participates in reviews and provides recommendations for business development opportunities.
• Ensures that biomarker sample collections, analyses, data transfers, and reporting are performed in accordance to the study protocol and in compliance with regulatory requirements.

Level and compensation will be commensurate with experience.
Qualifications:

• PhD with 6+ years of related work experience
• Master’s Degree with 12+ years of related work experience
• Bachelor’s Degree with 14+ years of related work experience

Preferred Qualifications:

• Strong scientific background in tumor biology and apoptosis, supported by publication record in these areas; expertise in hematologic malignancies is valued
• 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

Key Leadership Competencies:

• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Learns fast, grasps the "essence" and can change course quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.

Additional Information

• Significant Work Activities and Conditions: Keyboard use (greater or equal to 50% of the workday), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Travel: Yes, 5 % of the Time
• Job Type: Experienced
• Schedule: Full-time
• Job Level Code: M