Principal Scientist/Associate Director, Clinical Biomarker

Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18 Posted Date: Dec 4 2022 Job Purpose and Key Responsibilities : In close partnership with GSK Experimental Medicine Unit (EMU), lead the development, integration, and implementation of China biomarker strategy in alignment with global strategy, including supporting/facilitating validation and integration of biomarker assays into clinical trials for China. Accountability : Lead and/or contribute to China clinical asset biomarker strategy within early and late stage clinical development programs to generate data that informs on target engagement. pharmacodynamics, mechanism of action and patient selection. Serve as a member on China Oncology TMT, China Clinical Matrix Teams and study teams. Represent China Oncology TMT at global Clinical Matrix Teams (CMT) and clinical trial study teams (ST) on biomarker/CDx related topics. Serve as liaison between China Development Oncology TA and EMU Biomarker team; provide China insights and perspective to be incorporated in GSK global biomarker/diagnostic strategy for clinical development; ensure China TMT, CCMT and study teams are consulted and informed of global biomarker strategy relevant to China; Support development and implementation of novel biomarker assays in China Provide input to clinical teams on biomarker-related elements of 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 of contact for resolving study biomarker issues. Collaborate with clinical operations and sample management to ensure biomarker testing and data generation Align with the companion diagnostics team to deliver novel precision medicine approaches to select patients for treatment. Serve as a point of contact for external vendors and collaborators in support of data generation Provide frequent project status updates related to biomarker deliverables Provide support to HGRAC submission on biomarker deliverables Provide biomarker/CDx support to deliver regulatory submissions (IND and NDA, etc) Complexity: The holder will need to interact with and manage the expectations of internal stakeholders including but not limited to Clinical Sciences, Clinical Operation, Regulatory Affair, Experiment Medicine Unit (EMU), Global Asset team, Medical Information, Quality Assurance, and Commercials. The holder will need to interact with and manage the expectations of external stakeholders including but not limited to Biomarker/Dx vendors, HCPs, Investigators and regulatory reviewer Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Ph.D. or equivalent with minimum of 2 years or MA/MS with minimum 5 years of relevant experience in pharmaceutical industry setting in the application of biomarkers in clinical trials preferably in Oncology Proven track record of high-impact contributions to biomarker discovery and/or assay development Experience in 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 Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials. Knowledge and track-record of working to GCP principles Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment Flexibility to work on multiple projects as the portfolio evolves over time Strong interpersonal skills and ability to thrive in a matrix environment Proficient in both English and Chinese Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience in managing research collaborations, contract laboratories and budgets Demonstrated scientific capability as evidenced by publications, research reports, and external presentations. Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation Why GSK? 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: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. 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. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce. 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