Senior Director, Head of Diagnostic Execution

GSK • Upper Providence Township, PA

21h

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. 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 of Diagnostic Execution 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. This role is also responsible for optimizing processes, developing and communicating strategy, ensuring audit readiness, and ensuring overall operational excellence for the Translational Medicine Team.

Requirements

• MS or PhD degree in biological sciences or related discipline
• Minimum of 10 years of experience in the diagnostic, pharmaceutical, or biotech industry
• 5+ years managing an Operations team
• Strong background in Oncology
• Experience with drug discovery and development, clinical trial design, and principles of clinical development
• Experience in strategic set-up of central laboratory operations, study start up, clinical sample tracking/reconciliation and analysis
• Experience in discovery, development, outsourcing, and validation of clinically applicable BMx and Dx assays, including clinical validation and global diagnostic regulatory submissions requirements
• 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
• Proven track record of independent contributions to a strategic transformation of operations
• Demonstration of successful coaching/mentoring and direct people management skills
• Proven success leading teams, fostering team productivity and cohesiveness, and working collaboratively in a cross-functional environment
• Ability to thrive in a matrix environment and to interact effectively across boundaries using influencing & relationship building skills
• Experience in developing and implementing agile, creative solutions, helping to solve business challenges within the organization and in partnership with external collaborators
• Highly effective communication (verbal, written, and presentation) and interpersonal skills
• 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.)

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, IVD expertise, and global diagnostic regulatory requirements
• Serve as a key strategic liaison with stakeholders across Clinical Operations, Central HBSM, Biobank, Data Management, Procurement, Regulatory, and Quality Assurance; work to improve cross-functional processes across GSK
• Contribute to the continued building of a framework within the Operations function focusing on growth and development of new and “innovative” ways to work with internal and external partners
• Lead functional process and system improvements to ensure operational excellence
• Proactively support developing and reviewing standard processes and templates
• 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
• 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

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation, and 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: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees