Biosampling Therapeutic Area Lead (BTAL) Oncology
GSK
4 months ago
Remote friendly (Collegeville, PA)
United States
Operations
Job Title: Biosampling Oncology 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 assigned therapeutic area projects.
- Ensure the BPL team is resourced, trained, and equipped; coordinate with the HBSM Delivery leader to similarly equip the BPM team with project-specific knowledge.
- Identify and define opportunities to streamline HBS management delivery within the assigned therapeutic area (TA).
- Work with scientific functions and the DX operations head to define and implement HBS and Laboratory strategy, standardizing where possible for efficiency.
- Provide continuity and act as the senior escalation point for HBS and laboratory strategy across assigned projects.
- Align TA and project-level strategies with BPLs and cross-functional stakeholders.
- Provide TA-level oversight of external laboratories and vendors, supporting vendor selection with the TPO Head and Design Assurance.
- Lead functional process and system improvements to ensure operational excellence; maintain knowledge of relevant R&D science/portfolio/strategy.
- Track TA and CRO resource requirements and ensure appropriate resourcing to meet deliverables.
- Lead and influence senior leaders and cross-functional stakeholders; represent the department in internal/external meetings.
- Adhere to guidelines, SOPs, and technical/industry standards; drive inspection readiness and support audits.
- Manage risks and impacts within assigned therapeutic areas with proactive mitigation.
- Provide status updates; act as a subject matter expert (SME) and promote knowledge sharing.
Required Qualifications / Skills:
- Doctoral, Master’s, or Bachelor’s degree with equivalent experience.
- Extensive experience with central laboratory and clinical PK bioanalysis, PD biomarker, exploratory biomarker, immunogenicity and/or cellular assay delivery.
- In-depth knowledge of clinical development, GxP, and global regulatory requirements.
- Experience in Oncology Drug Development.
- Ability to coordinate multiple demands/timelines; influence stakeholders and manage expectations.
- Strong understanding of regulatory guidelines and legal requirements in major markets.
- Demonstrated ability to present to senior leaders and to lead/define strategy.
- Strong understanding of clinical safety, PK/PD/exploratory biomarker, immunogenicity, and related technical limitations, regulations, and certifications.
- Excellent organizational, interpersonal, and written/verbal communication skills.
Preferred Qualifications / Skills:
- Experience working with leaders to define strategies and deliverables.
- Knowledge of global regulatory requirements and expectations for sample analysis, including sample exportation.
- Experience with third-party laboratory contracting.
- Experience digitizing 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 assigned therapeutic area projects.
- Ensure the BPL team is resourced, trained, and equipped; coordinate with the HBSM Delivery leader to similarly equip the BPM team with project-specific knowledge.
- Identify and define opportunities to streamline HBS management delivery within the assigned therapeutic area (TA).
- Work with scientific functions and the DX operations head to define and implement HBS and Laboratory strategy, standardizing where possible for efficiency.
- Provide continuity and act as the senior escalation point for HBS and laboratory strategy across assigned projects.
- Align TA and project-level strategies with BPLs and cross-functional stakeholders.
- Provide TA-level oversight of external laboratories and vendors, supporting vendor selection with the TPO Head and Design Assurance.
- Lead functional process and system improvements to ensure operational excellence; maintain knowledge of relevant R&D science/portfolio/strategy.
- Track TA and CRO resource requirements and ensure appropriate resourcing to meet deliverables.
- Lead and influence senior leaders and cross-functional stakeholders; represent the department in internal/external meetings.
- Adhere to guidelines, SOPs, and technical/industry standards; drive inspection readiness and support audits.
- Manage risks and impacts within assigned therapeutic areas with proactive mitigation.
- Provide status updates; act as a subject matter expert (SME) and promote knowledge sharing.
Required Qualifications / Skills:
- Doctoral, Master’s, or Bachelor’s degree with equivalent experience.
- Extensive experience with central laboratory and clinical PK bioanalysis, PD biomarker, exploratory biomarker, immunogenicity and/or cellular assay delivery.
- In-depth knowledge of clinical development, GxP, and global regulatory requirements.
- Experience in Oncology Drug Development.
- Ability to coordinate multiple demands/timelines; influence stakeholders and manage expectations.
- Strong understanding of regulatory guidelines and legal requirements in major markets.
- Demonstrated ability to present to senior leaders and to lead/define strategy.
- Strong understanding of clinical safety, PK/PD/exploratory biomarker, immunogenicity, and related technical limitations, regulations, and certifications.
- Excellent organizational, interpersonal, and written/verbal communication skills.
Preferred Qualifications / Skills:
- Experience working with leaders to define strategies and deliverables.
- Knowledge of global regulatory requirements and expectations for sample analysis, including sample exportation.
- Experience with third-party laboratory contracting.
- Experience digitizing processes and electronic data capture.