Biosampling Therapeutic Area Leader (BTAL) Vaccines, ID, GH

GSK • Upper Providence, PA

4d

About The Position

As the Vaccines, GH and ID Biosampling Therapeutic Area Leader (BTAL) at GSK, you will play a pivotal role in driving the Human Biological Sample (HBS) and laboratory strategy for therapeutic programs across early and late-stage clinical development. You will lead a team of Biosampling Project Leaders (BPLs), ensuring operational excellence, resource alignment, and compliance with regulatory and scientific standards. This role requires Vaccnines, GH or ID area scientific knowledge, strong leadership, strategic vision, and the ability to collaborate across multidisciplinary teams to deliver high-quality biosampling operations and laboratory strategies that support GSK’s mission to get ahead of disease.

Requirements

• Doctoral degree, Master’s degree, or Bachelor’s degree and equivalent experience.
• Extensive experience with central Laboratory, clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay delivery requirements.
• Experience with vaccines, GH or ID drug development
• In-depth knowledge of the clinical development process, GxP, and global regulatory requirements.
• Experience coordinating multiple demands and timelines, stakeholder influence, and managing expectations
• Strong understanding of regulatory guidelines and legal requirements within major markets
• Demonstrated ability to present to senior leaders to achieve required investments
• Demonstrated ability to lead a group or team and define strategy for that group
• Strong understanding of clinical safety, PK Bioanalysis, PD Biomarker, Exploratory Biomarker, Immunogenicity, and/or cellular assay technical limitations and associated regulations and certifications
• Excellent organizational, interpersonal, and written/verbal communication skills with internal and external partners.

Nice To Haves

• Demonstratable experience working with leaders to define strategies and deliverables.
• Demonstrated knowledge of global regulatory requirements and expectations for sample analysis, including sample exportation.
• Experience of working with third party laboratory contracting
• Experience of digitalisation of processes and electronic data capture

Responsibilities

• Leadership & Team Management: Part of the extended leadership teams within GCO and the TA with the accountability to ensure all parties are aligned with the laboratory strategy for the TA. Accountable for the identification and definition of opportunities to streamline the delivery of the HBS management accountabilities within the assigned TA Accountable to lead and manage a team of Biosampling Project Leaders (BPLs) who are responsible for implementing HBS and laboratory strategies across projects within the assigned therapeutic areas. Accountable for ensuring the BPL team is resourced, trained, and equipped to manage their responsibilities and accountabilities effectively. Working with the BPL and the HBSM Delivery leader to ensure the BPM team is properly resourced, trained, and equipped with project specific knowledge to dispense their accountabilities effectively Provide coaching, mentoring, and professional development opportunities to team members, fostering a positive and motivating work environment.
• Strategic Oversight: Define with the scientific functions and DX operations head, the HBS and Laboratory strategy and drive the implementation for therapeutic programs in early and late-stage clinical development, driving standardisation wherever possible to bring efficiency gains . Accountable for continuity across assigned projects and act as the senior point of escalation for HBS and laboratory strategy. Align therapeutic area and project-level strategies by working closely with BPLs and cross-functional stakeholders. Provide TA-level oversight of external laboratories and vendors, ensuring optimal delivery of project objectives and appropriate vendor selection in collaboration with the TPO Head and Design Assurance.
• Operational Excellence: Maintain knowledge of the science, portfolio, and strategy of R&D across assigned therapeutic areas to deliver high-quality operational support for assets entering the clinical portfolio. Lead functional process and system improvements to ensure operational excellence. Identify and build capability models required within the team to meet deliverables and objectives successfully.
• Resource Management: Track resources within the assigned TA and address departmental or CRO resource requirements in a timely manner for key scientific programs, projects, and initiatives. Ensure the team is adequately resourced to meet operational demands and deliverables working with the IRM managers to ensure algorithms correctly assigned and projects requirements reflected.
• Stakeholder Engagement: Accountable to lead and influence senior leaders and cross-functional stakeholders to develop operational strategies and processes to support the assigned TA needs. Represent the department internally and externally in meetings and discussions, ensuring operations team representation during cross-functional workstreams.
• Compliance & Inspection Readiness: Adhere to guidelines, SOPs, practices, and technical and industry standards during all aspects of work. Accountable to drive inspection readiness by ensuring preparedness and compliance, supporting team members during inspections and audits.
• Risk Management: Accountable to manage risks and impacts within assigned therapeutic areas, ensuring proactive mitigation strategies are in place.
• Reporting & Communication: Provide regular status updates for areas of accountability/responsibility to key stakeholders as required. Act as a subject matter expert (SME) in assigned areas, promoting knowledge sharing and operational excellence.

What This Job Offers

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