Director, Clinical Biomarkers, Oncology

Role Summary

Director, Clinical Biomarkers, Oncology. Responsible for the development and implementation of biomarker and translational medicine strategies to support the clinical development of late-stage oncology assets. Collaborates with the Clinical Biomarker Executive Director to define decision-making criteria, patient segmentation, and integration into clinical development plans. Aims to discover and clinically validate biomarkers and align biomarker strategy with the clinical plan.

Responsibilities

• Collaborate with the Clinical Biomarker Executive Director to design, align, and execute clinical biomarker and translational medicine strategies to identify predictive biomarkers for clinical success.
• Validate and implement biomarker strategies, including target engagement, pharmacodynamic, and proof-of-mechanism biomarkers, to support patient stratification, dose selection, and go/no-go decisions.
• Participate in tumor-specific Biomarker Matrix teams to execute biomarker strategies for late-stage oncology programs, coordinating with internal/external stakeholders and disease area strategy teams.
• Represent Translational Medicine at Clinical Development Matrix Teams to establish biomarker-driven decision-making criteria and integrate into clinical study designs.
• Identify cutting-edge science and tech to inform biomarker strategies for indication selection, patient enrichment, and combination strategies.
• Oversee and/or develop sample testing plans and deliver high-quality biomarker data packages to inform clinical development and regulatory strategies.
• Manage relationships with clinical/scientific operations, diagnostics, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
• Support expansion of mechanism and disease understanding to generate insights for indication expansion and scientific exchange as needed.
• Contribute to scientific credibility through publications and presentations.

Qualifications

• Minimum of 5 years in the pharmaceutical industry with a solid background in oncology clinical biomarkers (late-phase oncology studies) and translational research within clinical development. Required
• Background as a Scientist and/or Physician. Required
• Proven ability to lead cross-functional teams and execute strategic biomarker plans. Required
• Experience conducting clinical trials and working as part of clinical study teams. Required
• Expertise in interpreting clinical biomarker data and evaluating innovative biomarker technologies for clinical trial applications. Required
• Strong interpersonal skills and ability to thrive in a team-oriented environment. Required
• Demonstrated ability to influence teams and key leaders, with a track record of success. Required

Preferred Qualifications

• Experience with high-dimensional dataset analysis. Preferred
• Expertise in identifying predictive biomarkers and/or diagnostic development. Preferred
• Excellent communication, problem-solving, and presentation skills. Preferred