Diagnostic Delivery Lead

GSK • Waltham, MA

22h

About The Position

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. T he 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 Associate Director, Dx Delivery Lead is experienced with therapeutic product and Dx co-development, project management, scenario planning, budgeting, HBS management, and managing external vendors and partners. The Dx Delivery Lead 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. The Associate Director leads 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:

Requirements

• Bachelor’s degree in biological sciences or related discipline
• 7+ 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave
• annual bonus
• eligibility to participate in our share based long term incentive program which is dependent on the level of the role

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees