GlaxoSmithKline Director – Biomarkers, Oncology EMU in Waltham, Massachusetts
Are you interested in the development and effective implementation of biomarker strategy to support projects across clinical development for novel assets in our new and emerging area of Oncology of interest, Synthetic Lethality and Epigenetics? Are you searching for a position where you will be working as a key contributor to clinical matrix team (CMT), medicines development team and leading development and integration of biomarker strategy into clinical development plans? If so, the Director Clinical Biomarkers Oncology role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Represent biomarker group at Development Teams 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 affair, regulatory, portfolio management and commercial functions
Establish and manage external collaborations with leading academic groups, diagnostic partners, and CROs
Contribute to scientific credibility of company through contributions to the scientific literature (publications/presentations)
Establish and deliver budget plans for biomarkers to MDT.
Working with Research Unit biology lead and EMU companion diagnostic lead to ensure alignment of preclinical, clinical biomarker strategies and CDx strategy
We are looking for professionals with these required skills to achieve our goals:
PhD degree in a related discipline
3 or more years of experience in Oncology Clinical Biomarkers and Translation Research
Extensive experience making contributions to biomarker discovery and implementation of biomarker strategy into clinical development
Highly 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
Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
Knowledge and track-record of working to GCP principles
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 interpersonal skills and ability to thrive in a matrix environment
Dependable and trustworthy, willing to take ownership and responsibility
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing . So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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