Clinical Biomarker Investigator, Cell and Gene Therapy (Oncology)
Site Name: UK - London - Brentford, USA - Pennsylvania - Upper Providence Posted Date: Aug 19 2021 Are you interested in developing and implementing innovative biomarker strategies for Cell and Gene Therapy and Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Biomarker Investigator role could be an ideal opportunity to explore. As an Experimental Medicine Unit (EMU) Biomarker Investigator, you will support efforts to enhance innovation using novel techniques to drive scientific excellence. You will contribute to the scientific advancement for the Biomarkers Group within the EMU whose objectives include determining drug mechanism of action, activity and relevant biological effects in patients. This role will provide YOU the opportunity to contribute to key activities to progress YOUR career. These responsibilities include some of the following: Support the 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. Be responsible for aspects of biomarker development from conception to execution. This will be accomplished by interfacing with colleagues across teams at GSK, as well as external CRO partners, to deliver the biomarker strategy and generate impactful and innovative data to drive clinical programs to be successful. Oversee technical aspects of biomarker assay development and implementation. Contribute to the writing and editing of the biomarker sections of the clinical protocol, study procedural manuals and consent forms. Collaborate with clinical operations and sample management to ensure biomarker testing and data generation is compliant with all regulatory requirements Ensure successful implementation of biomarker strategies in compliance with GSK policies and procedures including the Human Biological Sample Management. These include SOP development, appropriate language for protocol and consent forms, data standards, assessment of biomarker research proposals. Interact with Oncology clinical sites and partners to ensure accurate and appropriate clinical sample collection to support the biomarker strategy. Serve as a point of contact for external vendors and collaborators in support of data generation. Contribute to group's awareness of the emerging key scientific and technical innovations to help drive our continuous improvement Provide frequent project status updates related to biomarker deliverables. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: MA/MS in immunology, molecular biology, cancer biology, pathology or related field. A minimum of 2 years of relevant industrial experience is required with experience in translational or clinical research Minimum of one year experience in the clinical biomarkers or cell and gene therapy area Preferred Qualifications: If you have the following characteristics, it would be a plus: Ph.D. in immunology, molecular biology, molecular oncology, pathology or related field A proficient understanding of cancer cell biology and immuno-oncology is required Proven track record of supporting clinical biomarker or translational strategies and delivery of results 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 Ability to productively collaborate with multiple groups in a matrix environment Detail oriented with strong organizational skills in order to manage and meet deliverables Flexibility to work on multiple projects as the portfolio evolves over time. Intermediate to advanced level experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as WebEx and Skype 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. *LI-GSK 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. 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