Director - Biomarkers, Oncology Emu

Are you interested in the development of novel, integrated biomarker strategies to support projects across clinical development for Oncology? Are you searching for a position where you will be working as a key contributor to clinical matrix team (CMT), medicines development team (MDT) and leading development and integration of biomarker strategy into clinical development plans? If so, the Director, Clinical Biomarker role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.
Key Responsibilities:
• Represent biomarker group at Medicine Development Teams (MDT) and/or Clinical Matrix Teams (CMT). As part of the MDT/CMT, establishing clear biomarker driven decision-making criteria to enable clinical development.
• Identify cutting edge science and technological advances and incorporate them into biomarker strategies to guide indication selection, patient enrichment, and combination strategies.
• Develop translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives.
• Provide input to clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, lab manuals and consent forms.
• Oversight and/or development of sample testing plan and delivery of high-quality biomarker data packages to inform clinical development and regulatory strategy.
• Manage effective working relationships with clinical operations, medical science, medical affairs, regulatory, portfolio management and commercial functions
• Contribute to scientific credibility of company through contributions to the scientific literature (publications/presentations)
• Establish and deliver budget plans for biomarkers to MDT.
• Collaborate with Research Unit biology leads and EMU companion diagnostic leads to ensure alignment of preclinical, clinical biomarker strategies and CDx strategy
• Manage and/or mentor one or more direct reports or junior members of the team.
Why You?
Basic Qualifications:
• MS/MA with experience in the application of biomarkers in Oncology clinical trials at a manager or director level within the pharmaceutical or biotechnology industry
• Experience in the development of clinical biomarkers with a proven track record of success
• Experience in oncology translational research, with record of high-impact contributions to biomarker discovery and implementation of biomarker strategy into clinical development
• Experienced in conducting biomarker analyses on various clinical sample types
• Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams
• Experience with authoring clinical and regulatory documents
• Experience in up to date major cellular, molecular and genomic assay technologies and platforms
• Experience working to GCP principles
Preferred Qualifications:
• Higher degree (PhD) with industry experience in the application of biomarkers in Oncology clinical trials. Experience in Immuno-Oncology is preferred.
• Ability to influence teams and key stakeholders with a proven track record of success
• Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
• Strong communication and interpersonal skills
• Ability to thrive in a matrix environment
• Dependable and trustworthy, willing to take ownership and responsibility
#LI-GSK
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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