Director, Oncology Clinical Biomarkers

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 optimise decision-making in drug development and enable the identification of the right patient populations for our medicines.

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’s scientific credibility through publications and presentations.

Basic 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.

Preferred Qualifications

• Experience with high-dimensional dataset analysis.
• Expertise in identifying predictive biomarkers and/or diagnostic development.
• Excellent communication, problem-solving, and presentation skills.
• Strong interpersonal skills and ability to thrive in a team-oriented environment.

Benefits

Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.