Director, Clinical Biomarkers, Oncology

Role Summary

Director, Clinical Biomarkers, Oncology

In this role, you will be responsible for the development and effective implementation of biomarker and translational medicine strategies to support the clinical development of late-stage oncology assets. As a key member of a Clinical Matrix Team (CMT), 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. You will leverage cutting-edge technologies and methodologies to discover and clinically validate biomarkers, ensuring the biomarker strategy is fully aligned with the clinical plan. This integration will optimize decision-making in drug development and enable the identification of the right patient populations for our medicines.

Please note: This position requires an on-site office-based presence 2 to 3 days a week in the UK (Stevenage); or US (Upper Providence, PA. Waltham. MA)

Responsibilities

• Collaborating closely 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.
• Validating and implementing 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.
• Participating 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.
• Representing 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
• Identifying cutting-edge science and technological advances to incorporate into biomarker strategies for guiding indication selection, patient enrichment, and combination strategies.
• Overseeing and/or developing sample testing plans and delivering high-quality biomarker data packages to inform clinical development and regulatory strategies.
• Managing effective relationships with clinical and scientific operations, diagnostics, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
• Supporting the expansion of mechanism and disease understanding to generate insights for indication expansion and scientific exchange as needed.
• Contributing to the company‚Äôs scientific credibility through publications and presentations.

Qualifications

• 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.
• 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.

Preferred Qualifications

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