Biosampling Therapeutic Area Leader (BTAL) Vaccines, ID, GH
GSK
5 months ago
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Vaccines, GH and ID Biosampling Therapeutic Area Leader (BTAL)
Responsibilities:
- Drive Human Biological Sample (HBS) and laboratory strategy for therapeutic programs across early and late-stage clinical development.
- Lead and manage a team of Biosampling Project Leaders (BPLs) to implement HBS and laboratory strategies across projects.
- Ensure the BPL team is resourced, trained, and equipped; support resourcing/training for the BPM team with project-specific knowledge.
- Provide coaching, mentoring, and professional development.
- Define HBS and Laboratory strategy with scientific functions and DX operations head; implement for therapeutic programs and drive standardisation to improve efficiency.
- Ensure continuity across projects; act as senior escalation point for HBS and laboratory strategy.
- Align therapeutic area and project-level strategies with BPLs and cross-functional stakeholders.
- Oversee external laboratories/vendors and ensure appropriate vendor selection.
- Maintain knowledge of R&D science/portfolio/strategy; lead process and system improvements for operational excellence.
- Identify and build team capability models to meet deliverables.
- Track TA resources and address departmental/CRO resource needs; coordinate with IRM managers.
- Lead stakeholder engagement with senior leaders and cross-functional partners; provide updates as needed.
- Promote knowledge sharing as a subject matter expert (SME).
- Adhere to guidelines/SOPs/industry and technical standards; drive inspection readiness and compliance.
- Manage risks and impacts with proactive mitigation.
Required Qualifications / Skills:
- Doctoral, Master’s, or Bachelor’s degree with equivalent experience.
- Extensive experience with central Laboratory and clinical PK Bioanalysis, PD/Exploratory Biomarker, Immunogenicity, and/or cellular assay delivery.
- Experience with vaccines, GH or ID drug development.
- In-depth knowledge of clinical development, GxP, and global regulatory requirements.
- Ability to coordinate multiple demands/timelines, influence stakeholders, and manage expectations.
- Strong understanding of regulatory guidelines/legal requirements in major markets.
- Demonstrated ability to present to senior leaders and define/lead strategy for a team.
- Strong understanding of clinical safety and technical limitations plus associated regulations/certifications.
- Excellent organizational, interpersonal, and written/verbal communication skills.
Preferred Qualifications:
- Experience defining strategies and deliverables with leaders.
- Knowledge of global regulatory expectations for sample analysis, including sample exportation.
- Experience contracting third-party laboratories.
- Experience with digitalisation of processes and electronic data capture.
Responsibilities:
- Drive Human Biological Sample (HBS) and laboratory strategy for therapeutic programs across early and late-stage clinical development.
- Lead and manage a team of Biosampling Project Leaders (BPLs) to implement HBS and laboratory strategies across projects.
- Ensure the BPL team is resourced, trained, and equipped; support resourcing/training for the BPM team with project-specific knowledge.
- Provide coaching, mentoring, and professional development.
- Define HBS and Laboratory strategy with scientific functions and DX operations head; implement for therapeutic programs and drive standardisation to improve efficiency.
- Ensure continuity across projects; act as senior escalation point for HBS and laboratory strategy.
- Align therapeutic area and project-level strategies with BPLs and cross-functional stakeholders.
- Oversee external laboratories/vendors and ensure appropriate vendor selection.
- Maintain knowledge of R&D science/portfolio/strategy; lead process and system improvements for operational excellence.
- Identify and build team capability models to meet deliverables.
- Track TA resources and address departmental/CRO resource needs; coordinate with IRM managers.
- Lead stakeholder engagement with senior leaders and cross-functional partners; provide updates as needed.
- Promote knowledge sharing as a subject matter expert (SME).
- Adhere to guidelines/SOPs/industry and technical standards; drive inspection readiness and compliance.
- Manage risks and impacts with proactive mitigation.
Required Qualifications / Skills:
- Doctoral, Master’s, or Bachelor’s degree with equivalent experience.
- Extensive experience with central Laboratory and clinical PK Bioanalysis, PD/Exploratory Biomarker, Immunogenicity, and/or cellular assay delivery.
- Experience with vaccines, GH or ID drug development.
- In-depth knowledge of clinical development, GxP, and global regulatory requirements.
- Ability to coordinate multiple demands/timelines, influence stakeholders, and manage expectations.
- Strong understanding of regulatory guidelines/legal requirements in major markets.
- Demonstrated ability to present to senior leaders and define/lead strategy for a team.
- Strong understanding of clinical safety and technical limitations plus associated regulations/certifications.
- Excellent organizational, interpersonal, and written/verbal communication skills.
Preferred Qualifications:
- Experience defining strategies and deliverables with leaders.
- Knowledge of global regulatory expectations for sample analysis, including sample exportation.
- Experience contracting third-party laboratories.
- Experience with digitalisation of processes and electronic data capture.