Director, Clinical Biomarkers, Oncology

Role Summary

Director, Clinical Biomarkers, Oncology. Responsible for the development and effective 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 establish criteria, define patient segmentation, and integrate into clinical development plans. Leverages modern technologies to discover and validate biomarkers, ensuring alignment with the clinical plan.

Responsibilities

• Collaborate with the Clinical Biomarker Executive Director to design, align, and execute biomarker and translational medicine strategies focused on identifying predictive biomarkers that enable clinical success.
• Validate and implement biomarker strategies (target engagement, pharmacodynamic, and proof-of-mechanism biomarkers) for clinical-phase programs to support patient stratification, dose selection, and go/no-go decisions.
• Participate in tumor-specific Biomarker Matrix teams, executing clinical biomarker strategies for late-stage oncology programs with internal/external stakeholders and disease area teams.
• Represent Translational Medicine at Clinical Development Matrix Teams to establish biomarker-driven decision-making criteria and integrate them into clinical study designs.
• Identify cutting-edge science and tech advances to incorporate into 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 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

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

Skills

• Biomarker strategy development
• Tumor biomarker matrix collaboration
• Translational medicine and clinical development alignment
• Data interpretation and biomarker technology evaluation
• Cross-functional leadership and stakeholder management

Education

• Background as a Scientist and/or Physician (as applicable)