Director, Oncology Clinical Biomarkers
GSK
9 hours ago
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Responsibilities:
- Collaborate with the Clinical Biomarker Executive Director to design, align, and execute clinical biomarker and translational medicine 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 for late-stage oncology programs within tumor-specific Biomarker Matrix teams with internal/external stakeholders and disease area strategy teams.
- Represent Translational Medicine at Clinical Development Matrix Teams (CMT) to define biomarker-driven decision-making criteria and integrate them into clinical study designs.
- Identify and incorporate cutting-edge science/technology to guide indication selection, patient enrichment, and combination strategies.
- Oversee/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 mechanism/disease understanding expansion and contribute via publications/presentations.
Basic Qualifications:
- PhD in Life Sciences or Medical degree.
- 5+ years pharma experience with oncology clinical biomarkers (late-phase oncology) and translational research in clinical development.
- Experience leading cross-functional teams; conducting clinical trials.
- Ability to interpret clinical biomarker data and evaluate biomarker technologies for trials.
- Experience influencing teams and key leaders.
Preferred Qualifications:
- High-dimensional dataset analysis.
- Predictive biomarker and/or diagnostic development experience.
- Strong communication, problem-solving, presentation, and interpersonal skills.
Benefits (if applicable in posting):
- Annual bonus; share-based long-term incentive; health care/insurance, retirement, paid holidays/vacation, and paid caregiver/parental and medical leave.
- Collaborate with the Clinical Biomarker Executive Director to design, align, and execute clinical biomarker and translational medicine 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 for late-stage oncology programs within tumor-specific Biomarker Matrix teams with internal/external stakeholders and disease area strategy teams.
- Represent Translational Medicine at Clinical Development Matrix Teams (CMT) to define biomarker-driven decision-making criteria and integrate them into clinical study designs.
- Identify and incorporate cutting-edge science/technology to guide indication selection, patient enrichment, and combination strategies.
- Oversee/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 mechanism/disease understanding expansion and contribute via publications/presentations.
Basic Qualifications:
- PhD in Life Sciences or Medical degree.
- 5+ years pharma experience with oncology clinical biomarkers (late-phase oncology) and translational research in clinical development.
- Experience leading cross-functional teams; conducting clinical trials.
- Ability to interpret clinical biomarker data and evaluate biomarker technologies for trials.
- Experience influencing teams and key leaders.
Preferred Qualifications:
- High-dimensional dataset analysis.
- Predictive biomarker and/or diagnostic development experience.
- Strong communication, problem-solving, presentation, and interpersonal skills.
Benefits (if applicable in posting):
- Annual bonus; share-based long-term incentive; health care/insurance, retirement, paid holidays/vacation, and paid caregiver/parental and medical leave.