Director, Oncology Clinical Biomarkers

Director Oncology Clinical Biomarkers

Job Purpose:
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 companys scientific credibility through publications and presentations.

Why You

Basic Qualifications:
We are looking for professionals with the following required skills and experience:

• 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:
The following qualifications would be advantageous:

• 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.

#LI-GSK*

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

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Director