Director, Clinical Biomarkers, Oncology
GSKAbout the role
Director, Clinical Biomarkers, Oncology
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
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
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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.
Why You?
Basic Qualifications:
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- 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 Qualification
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