GSK
Director, Clinical Biomarkers, Oncology
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 that is ambitious for patients, accountable for impact, and committed to doing the right thing, while accelerating assets that meet patients’ needs with the highest probability of success.
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.
This position requires an on‑site office‑based presence 2 to 3 days a week in the UK (Stevenage) or the US (Upper Providence, PA / Waltham, MA).
Responsibilities
Collaborate 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.
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 and 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.
Manage effective relationships with clinical and scientific operations, diagnostics, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
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.
Basic 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.
#J-18808-Ljbffr
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.
This position requires an on‑site office‑based presence 2 to 3 days a week in the UK (Stevenage) or the US (Upper Providence, PA / Waltham, MA).
Responsibilities
Collaborate 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.
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 and 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.
Manage effective relationships with clinical and scientific operations, diagnostics, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
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.
Basic 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.
#J-18808-Ljbffr