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Biosampling Therapeutic Area Lead (BTAL) Oncology
Biosampling Oncology Therapeutic Area Leader
This role leads the Human Biological Sample (HBS) and laboratory strategy for therapeutic programs across early and late‑stage clinical development. It involves managing a team of Biosampling Project Leaders, ensuring operational excellence, regulatory compliance and strategic collaboration across multidisciplinary teams to support GSK's mission.
Key Responsibilities
Accountable for aligning laboratory strategy with the extended leadership teams within GCO and the Therapeutic Area.
Identify and define opportunities to streamline the delivery of HBS management within the assigned TA.
Lead and manage a team of Biosampling Project Leaders responsible for implementing HBS and laboratory strategies across projects.
Ensure BPL team is resourced, trained and equipped to manage responsibilities effectively.
Collaborate with the HBSM Delivery leader to ensure the BPM team is properly resourced, trained and equipped with project‑specific knowledge.
Provide coaching, mentoring and professional development to foster a positive work environment.
Define, with scientific functions and DX operations head, the HBS and laboratory strategy and drive its implementation across therapeutic programs.
Serve as senior escalation point for HBS and laboratory strategy, ensuring continuity across assigned projects.
Align TA and project‑level strategies by collaborating with BPLs and cross‑functional stakeholders.
Provide TA‑level oversight of external laboratories and vendors, ensuring optimal delivery of project objectives.
Maintain knowledge of R&D science, portfolio and strategy within assigned therapeutic areas.
Lead functional process and system improvements to ensure operational excellence.
Identify and build capability models required to meet deliverables.
Track resources and address departmental or CRO resource requirements in a timely manner.
Engage senior leaders and stakeholders to develop operational strategies and processes.
Represent the department internally and externally in meetings and discussions.
Adhere to guidelines, SOPs, and industry standards during all work.
Drive inspection readiness and support team members during audits.
Manage risks and impacts within assigned TA, ensuring proactive mitigation.
Provide regular status updates to stakeholders.
Act as subject‑matter expert, promoting knowledge sharing and operational excellence.
Required Skills and Qualifications
Doctoral, Master’s, Bachelor’s degree or equivalent experience.
Extensive experience with central laboratory, clinical PK bioanalysis, PD biomarker, exploratory biomarker, immunogenicity and/or cellular assay delivery.
In‑depth knowledge of the clinical development process, GxP, and global regulatory requirements.
Experience in Oncology drug development.
Ability to coordinate multiple demands, timelines and manage expectations.
Strong understanding of regulatory guidelines and legal requirements in major markets.
Demonstrated ability to present to senior leaders for investment decisions.
Experience leading a group or team and defining strategy for that group.
Strong understanding of clinical safety, PK bioanalysis, PD biomarker, exploratory biomarker, immunogenicity and/or cellular assay technical limits and associated regulations.
Excellent organizational, interpersonal and communication skills.
Preferred Qualifications
Experience working with leaders to define strategies and deliverables.
Knowledge of global regulatory requirements and expectations for sample analysis, including exportation.
Experience with third‑party laboratory contracting.
Experience in digitalisation of processes and electronic data capture.
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. 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, military service or any basis prohibited under federal, state or local law.
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