Head, Diagnostic Operations

SUMMARY: 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 (Dx) strategy leads, Clinical 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 Head, Diagnostic Operations is accountable for leading this highly skilled technical team of Dx Delivery professionals, with responsibility for line management, training, oversight and retention, ensuring the team is resourced and trained to manage their accountabilities effectively. In addition, the successful candidate will be experienced in facilitating therapeutic product and/or Dx co-development, project management, scenario planning, budgeting, HBS management, and managing external vendors and partners. KEY RESPONSIBILITIES: Lead a team of diagnostic operations professionals to implement clinical biomarker and diagnostic plans for therapeutic programs in early and late-stage clinical development Line management, training, oversight, and retention of diagnostic operations professionals Maintain knowledge of the science, technology, portfolio, and strategy of R&D across Oncology and deliver high-quality diagnostic operations support Engage with and influence leaders and cross-functional stakeholders to develop diagnostic operational strategies by leveraging broad knowledge of biomarker technologies, diagnostic development, and IVD expertise Apply and adhere to ICH/GCP, HBS management best practices, regulatory guidelines, ethical guidelines, and technical and industry standards during all aspects of work, ensuring inspection readiness by ensuring preparedness and compliance; support team members in connection with inspections and audits Lead functional process and system improvements to ensure operational excellence and identify and build the capability required within the team to ensure deliverables and objectives are successfully met Work with stakeholders to improve cross-functional processes GSK Represent the Dx Planning & Execution department internally and externally in meetings and discussions as required, and ensure representation of the Dx Delivery team during cross-functional workstreams Set a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels by role modelling the GSK values BASIC QUALIFICATIONS: MS or PhD degree in biological sciences or related discipline Minimum of 10 years of experience in the diagnostic, pharmaceutical, or biotech industry Knowledge and experience in drug discovery and development, clinical trial design, and principles of clinical development Experience in discovery, development, outsourcing, and validation of clinically applicable BMx and Dx assays, including clinical validation and global diagnostic regulatory submissions requirements Experience deploying BMx and Dx assays in a clinical development context Previous Oncology experience Line management experience Preferred qualifications: Experience in clinical trial specimen management, including collection/processing of diverse sample types, LIMS, laboratory management and oversight, and global regulatory requirements and expectations for sample analysis, including sample exportation Experience interacting with regulatory agencies for Dx Highly effective communication (verbal, written, and presentation) and interpersonal skills 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 Established expertise and hands-on experience with MS Office applications (Word, Excel, PowerPoint), Outlook, SharePoint, remote meeting tools such as MS Teams, WebEx, etc. and a working understanding of innovative AI technologies (e.g., CoPilot, ChatGPT, GiGi, Jules, PowerBI, etc.) Demonstrated ability to think strategically, work effectively in a matrixed environment, and execute multiple projects simultaneously 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. 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. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ #J-18808-Ljbffr