Director, Oncology Clinical Biomarkers

About the role

The Clinical Biomarker Director will collaborate with the Clinical Biomarker Executive Director to establish clear decision-making criteria, define patient segmentation strategies, and integrate these into clinical development plans. Leveraging cutting-edge technologies and methodologies, the Clinical Biomarker Director will discover and clinically validate biomarkers, ensuring they are fully aligned with the clinical plan.

Responsibilities

• Collaborate with the Clinical Biomarker Executive Director to drive the design, alignment, and execution of clinical biomarker and translational medicine strategies focused on identifying predictive biomarkers that enable clinical success.
• Validate and implement biomarker strategies, including target engagement, pharmacodynamic, and proof-of-mechanism biomarkers, for clinical-phase programs to support patient stratification, dose selection, and enable clinical go/no-go decisions.
• Participate in tumor-specific Biomarker Matrix teams, with responsibility for executing clinical biomarker strategies for late-stage oncology programs, while working closely with internal and external stakeholders, as well as disease area strategy teams.
• Represent Translational Medicine at Clinical Development Matrix Teams (CMT) to establish biomarker-driven decision-making criteria and their seamless integration into clinical study designs, aligning with clinical study objectives.
• Identify cutting-edge science and technological advances to incorporate into biomarker strategies for guiding 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.
• Support the expansion of mechanism and disease understanding to generate insights for indication expansion and scientific exchange as needed.
• Contribute to the company’s scientific credibility through publications and presentations.

Qualifications

• PhD in Life Sciences or Medical degree.
• Minimum of 5 years of experience in the pharmaceutical industry, with a solid background in oncology clinical biomarkers - expertise in late-phase oncology studies - and translational research within clinical development.
• Experience in leading cross-functional teams and executing strategic biomarker plans.
• Experience in 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.
• Experience in influencing teams and key leaders.

Benefits

• Annual base salary range: $189,750 to $316,250.
• Comprehensive benefits program including health care and other insurance benefits, retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.