Site Name: USA - Massachusetts
Waltham, USA - Pennsylvania
Posted Date: Mar 6 2020
Are you interested in the development of biomarker strategies to support projects across clinical development for Epigenetic and Synthetic Lethality assets in Oncology? Are you searching for a position where you will be working as a key contributor to clinical matrix team (CMT) and leading development and integration of biomarker strategy into clinical development plans? If so, the Clinical Biomarker Lead role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.
As an Experimental Medicine Lead, you will be responsible for the development and effective implementation of biomarker strategies to support projects across clinical development for either epigenetic and/or synthetic lethality assets.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Represent biomarker lead at clinical matrix team (CMT) and clinical trial study teams (ST). As part of the CMT and clinical ST, establishing clear decision-making criteria to enable informed clinical decisions.
Identify, develop and implement cutting edge science and technological advances into biomarker and companion diagnostic (CDx) 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.
Provide scientific expertise and technical guidance to enable timely biomarker sample collection.
Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy. Point contact for resolving study biomarker issues.
Manage effective working relationships with clinical operations, medical science, medical affair, and regulatory 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)
Working with Research Unit biology lead and EMU companion diagnostic lead to ensure alignment of preclinical and clinical biomarker strategies and to implement development of CDx strategy
We are looking for professionals with these required skills to achieve our goals:
Ph.D. or equivalent with minimal 2-5 years or M.Sc with minimum 5-8 of relevant experience in biotechnology or pharmaceutical industry setting in the application of biomarkers in clinical trials preferably in oncology biomarker development.
Extensive experience in the development of clinical biomarkers with a proven track record of success
Highly experienced in oncology translational research on molecularly targeted therapies or IO therapies, with proven track record of high-impact contributions to biomarker discovery and/or assay development
Experience in conducting clinical trials, conducting biomarker analyses on various clinical sample types and working as part of a clinical study team
Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
Experience with authoring clinical and regulatory documents
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
If you have the following characteristics, it would be a plus:
Preference for candidates with knowledge or experience in the development of co-diagnostic strategies.
Experience in managing research collaborations, contract laboratories and budgets
Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
Managing individual and team performance.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in teams.
Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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