Director, Oncology Clinical Biomarkers
GSK
7 hours ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Director, Oncology Clinical Biomarkers
Job Purpose:
- Develop and implement biomarker and translational medicine strategies to support late-stage oncology clinical development.
- Collaborate with leadership to define decision criteria, patient segmentation, and integrate them into clinical development plans; discover and validate biomarkers aligned with the clinical plan.
Responsibilities:
- Collaborate with the Clinical Biomarker Executive Director to design, align, and execute clinical biomarker and translational strategies for predictive biomarkers.
- Validate and implement biomarker strategies (target engagement, pharmacodynamic, proof-of-mechanism) to support patient stratification, dose selection, and clinical go/no-go decisions.
- Execute clinical biomarker strategies in tumor-specific Biomarker Matrix teams with internal/external stakeholders and disease area strategy teams.
- Represent Translational Medicine at Clinical Development Matrix Teams (CMT) to integrate biomarker-driven decision criteria into clinical study designs.
- Incorporate cutting-edge science/technology to guide indication selection, patient enrichment, and combination strategies.
- Oversee and/or develop sample testing plans and deliver high-quality biomarker data packages for clinical development and regulatory strategies.
- Manage relationships across clinical/scientific operations, diagnostics, medical science/affairs, regulatory, portfolio management, and commercial functions.
- Support expansion of mechanism and disease understanding for indication expansion and scientific exchange.
- Contribute to scientific credibility via publications and presentations.
Basic Qualifications (Required):
- PhD in Life Sciences or Medical degree.
- 5+ years in the pharmaceutical industry with oncology clinical biomarkers and translational research in clinical development (late-phase oncology studies).
- Experience leading cross-functional teams and executing strategic biomarker plans.
- Experience conducting clinical trials and working on clinical study teams.
- Expertise interpreting clinical biomarker data and evaluating biomarker technologies for clinical trials.
- Experience 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.
Job Purpose:
- Develop and implement biomarker and translational medicine strategies to support late-stage oncology clinical development.
- Collaborate with leadership to define decision criteria, patient segmentation, and integrate them into clinical development plans; discover and validate biomarkers aligned with the clinical plan.
Responsibilities:
- Collaborate with the Clinical Biomarker Executive Director to design, align, and execute clinical biomarker and translational strategies for predictive biomarkers.
- Validate and implement biomarker strategies (target engagement, pharmacodynamic, proof-of-mechanism) to support patient stratification, dose selection, and clinical go/no-go decisions.
- Execute clinical biomarker strategies in tumor-specific Biomarker Matrix teams with internal/external stakeholders and disease area strategy teams.
- Represent Translational Medicine at Clinical Development Matrix Teams (CMT) to integrate biomarker-driven decision criteria into clinical study designs.
- Incorporate cutting-edge science/technology to guide indication selection, patient enrichment, and combination strategies.
- Oversee and/or develop sample testing plans and deliver high-quality biomarker data packages for clinical development and regulatory strategies.
- Manage relationships across clinical/scientific operations, diagnostics, medical science/affairs, regulatory, portfolio management, and commercial functions.
- Support expansion of mechanism and disease understanding for indication expansion and scientific exchange.
- Contribute to scientific credibility via publications and presentations.
Basic Qualifications (Required):
- PhD in Life Sciences or Medical degree.
- 5+ years in the pharmaceutical industry with oncology clinical biomarkers and translational research in clinical development (late-phase oncology studies).
- Experience leading cross-functional teams and executing strategic biomarker plans.
- Experience conducting clinical trials and working on clinical study teams.
- Expertise interpreting clinical biomarker data and evaluating biomarker technologies for clinical trials.
- Experience 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.