GSK site preferred locations: US - Waltham, MA,Upper Providence, PA. UK – GSK House, Stevenage. Switzerland. On-site presence of 2-3 days per week average is anticipated. Additional flexible arrangements considered on case by case basis.
1. Leading the conceptualization, alignment and delivery of Clinical Biomarker Strategies on behalf of Precision Medicine
2. Representing Precision Medicine at Medicine Development Teams (MDT) and/or Clinical Matrix Teams (CMT) establishing clear biomarker driven decision-making criteria to enable clinical development.
3. Identify cutting edge science and technological advances and incorporate them into biomarker strategies to guide indication selection, patient enrichment, and combination strategies.
4. Develop translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives.
5. Oversight and/or development of sample testing plan and delivery of high-quality biomarker data packages to inform clinical development and regulatory strategy.
6. Manage effective working relationships with clinical operations, medical science, medical affairs, regulatory, portfolio management and commercial functions
7. Establish and manage external collaborations with leading academic groups, diagnostic partners, and CROs
8. Contribute to scientific credibility of company through contributions to the scientific literature (publications/presentations)
9. Establish and deliver budget plans for biomarkers to MDT.
10. Working with Research Unit biology leads and Precision Medicine Companion Diagnostic leads to ensure alignment of preclinical, clinical biomarker and CDx strategies
Basic Qualifications:
11. Bachelor’s degree in oncology, immunology or a related discipline required. PhD preferred.
12. 7+ years of experience in Clinical Biomarkers and Translational Research
Preferred Qualifications:
13. Expertise in leading the development of clinical biomarker strategies with a proven track record of success
14. Extensive experience in oncology translational research, with proven track record of high-impact contributions to biomarker discovery and implementation of biomarker strategy into clinical development
15. Demonstrable leadership of matrix team structures across functional disciplines
16. Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams
17. Ability to influence teams and key stakeholders with a proven track record of success
18. Experience with authoring clinical and regulatory documents
19. Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
20. Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
21. Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials.
22. Knowledge and track-record of working to GCP principles
23. Strong interpersonal skills and ability to thrive in a matrix environment
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