Investigator, Diagnostic Delivery
Stevenage, UK
The Diagnostic (Dx) Delivery Team within Oncology Translational Medicine (OTM) is a dedicated group of scientific operations professionals that drive the implementation of clinical diagnostic strategy for therapeutic programs in early and late-stage Oncology clinical development. The Dx Delivery Team leverages subject matter expertise to progress Dx activities and deliverables in collaboration with Diagnostic strategy leads, Clinical and Translational Biomarkers (BMx), Precision Medicine & Digital Health Regulatory, Clinical Operations, Human Biological Sample Management, Data Management, Quality, Procurement, and Finance, as well as external CRO laboratories, central laboratories, collaborators, and Dx manufacturers. The team oversees implementation of clinical trial assays at reference labs and centralized testing vendors through contract execution and vendor oversight, ensures integration of relevant Dx content in clinical study documents and associated systems (i.e. clinical protocol, informed consent forms, eCRFs, CSRs, etc.), manages HBS and logistics to support the clinical trial schedule, ensures data is ready for analysis per timeline and oversees data transfer, and resolves or escalates Dx study-related issues.
The Investigator- Dx Delivery is experienced with therapeutic product and Dx co-development, project management, scenario planning, budgeting, HBS management, and managing external vendors and partners. The Investigator, Dx Delivery provides the operational expertise needed to consistently implement the operational delivery of diagnostic strategies developed by the Precision Diagnostics Team within clinical trials, ensuring audit readiness at all times. TheInvestigator, Dx Delivery the diagnostic operational strategies of larger programs, executing the strategy within a subset of studies, and overseeing execution by Investigators within their assigned studies.
Responsibilities include:
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Drives the implementation of clinical diagnostic plans for therapeutic programs in early and late stage clinical development across Oncology, ensuring audit readiness
Accountable for the development of the clinical study’s diagnostics biosample collection, processing and storage strategies and ensuring their logistical feasibility and cost effectiveness
Accountable for planning and implementing the diagnostic biosample collection within a clinical study including definition of the appropriate material, instructions, lab manual development & review, kit development, database set up, etc.
Accountable for forecasting and planning of biosample analysis and sample management costs within projects or clinical studies
Contributes to study protocols and ICFs prior to finalization and provides input to ensure the protocol and ICFs enable sample testing according to the diagnostic plan
Work with Clinical Operations to draft Site Communications and Training Materials; train CRO and internal teams on sample collection/processing activities as required
Project manages the implementation of clinical trial assays at reference labs and centralized testing vendors, ensures delivery of assay/data results and is a key contact for the assay lab
Ensures alignment of outputs with the requirements of Data Management and Biostatistics, and provide expert input into data transfer agreements
Serves as first point of contact for diagnostic biosample operational questions and issues within a project and coordinates with internal and external partners (e.g., Laboratory Study Management, Clinical Operations, Diagnostic Leads, and CROs)
Provide regular study-level status updates for areas of accountability/responsibility to key stakeholders including diagnostic biosample tracking reports for select samples for analysis
Accountable for the identification, documentation, and management of risks within projects
Lead or contribute to functional process and system improvements to ensure operational excellence
Accountable for a specialty area of process, training, or governance task as assigned
Provide coaching and mentoring within the team, acting as a Subject Matter Expert in assigned areas
Foster a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels, by role modeling the GSK values
Why You?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree in biological sciences or related discipline
4+ years of industry experience
Experience in clinical trial specimen management
Experience overseeing third‑party vendors and laboratories, including contracting activities
Professional experience within the Oncology therapeutic area
Experience with diagnostic assay development and validation
Preferred Experience
If you have the following characteristics, it would be a plus:
Doctoral degree, Master’s degree, or equivalent experience
Matrix management and/or line management experience
Experience in collection and processing of diverse sample types, LIMS, and project management
Excellent communication skills, interpersonal skills, and matrix working skills
Self-motivated with the ability to work independently, as well as a highly motivated team player with a proactive attitude and ability to interact effectively within a multi-disciplinary team, including internal and external technical and business experts
Demonstrated knowledge of global diagnostic regulatory requirements and expectations for sample analysis, including sample exportation
#GSK-LI
What we value in you
You are collaborative and clear in communication. You use sound judgement and act with integrity. You take ownership of delivery and help others do the same. You enjoy mentoring colleagues and improving ways of working. You will help create an inclusive team where different perspectives are welcomed.
How to apply
If this role motivates you and you meet the basic qualifications, we would love to hear from you. Submit your application and a short note explaining what excites you about this opportunity and how your experience matches the role.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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