Lab Execution and Delivery Lead

Background and Job Purpose:

As Asia Translational Medicine (ATM) assumes operational accountability for China-only studies, a dedicated laboratory execution role is required to ensure that translational and biomarker requirements are converted into compliant, timely and decision-ready study delivery. This role provides BPL/BPM-like execution accountability within ATM for China-only studies, while aligning with global Platform Sciences/HBS S&D standards and ATM operating model expectations.

The ATM Lab Execution & Delivery Lead owns end-to-end study-level lab operations execution across sample flow, assay readiness, central/specialty/local lab model, vendor oversight, data transfer and reconciliation, compliance documentation and study close-out.

Accountabilities:

The role is accountable for:

Study lab execution planning

Conver protocol and biomarker requirements into executable lab operation plans

Lab execution plan; study up readiness tracking, lab manual input, risk log etc.

Sample flow and custody

Own operational visibility of sample collection, shipment, tracking, storage, reuse/disposition, and reconciliation

Sample flow map, tracker, logistics plan, reconciliation package

Assay and lab readiness

Coordinate assay readiness with BBP/scientific leads and central/specialty labs

Assay readiness checklist, lab capability assessment, transfer/valuation tracker etc

Vendor and lab oversight

Manage day to day central, specialty lab, local lab, CRO and logistics vendor deliverables

Vendor action log, milestones tracking, issue/escalation log etc, performance follow-up

Data handoff and close out

Ensure sample-to-data reconciliation and handoff tro DM, CPMS, Omics, predictive science and statistics

Data transfer tracker, query log, handoff checklist, close out files etc.

Compliance readiness

Support ICH/GCP, GxP, HGRAC/CIQ, eTMF and inspection readiness for lab activities

Compliance checklist, documentation completeness tracker, deviation/CAPA support etc

Key Responsibilities

Act as ATM lab execution owner for assigned China-only studies, providing BPL/BPM-like operational accountability.

Create and maintain study-level lab execution plans covering sample, assay, lab/vendor, data and compliance requirements.

Review protocol, ICF, lab manual, sample management documents, data transfer specifications and vendor deliverables for operational feasibility.

Coordinate sample collection, logistics, shipment, testing status, reconciliation, storage, reuse/disposition and issue management.

Coordinate assay and laboratory readiness with BBP, Platform Sciences, scientific leads and external laboratories.

Provide day-to-day oversight of central/specialty/local laboratories, CROs and logistics vendors, including milestone tracking and issue escalation.

Ensure lab data delivery readiness, including sample-to-data reconciliation, query follow-up and downstream handoff.

Maintain inspection-ready documentation and support GxP, ICH/GCP, HGRAC/CIQ, eTMF and quality requirements.

Partner with Maria to surface study execution learnings that inform ATM implementation, adoption and continuous improvement.

Partner with Helen to escalate systemic risks, capability gaps and operating model improvement needs.

This role

Owns China-only study lab execution, not ATM strategy or operating model design.

Does not own scientific rationale or biomarker strategy, but translates scientific requirements into executable lab delivery.

Supports global studies with China components according to agreed RACI and global model, while China-only studies are the primary accountability.

Qualifications

Basic qualifications

Bachelor degree or above in life sciences, laboratory science, pharmacy, medicine, clinical research or related field.

Experience in clinical trial sample management, lab operations, biomarker operations, central/specialty lab management, CRO/vendor oversight or clinical operations.

Preferred qualifications

Experience with China clinical trial environment, HGRAC/CIQ considerations, PK/PD/ADA/biomarker/omics workflows, data transfer/reconciliation, vendor oversight and regulated documentation.

Strong attention to detail, issue management and cross-functional communication.

Preferred Skills & Capabilities

Relevant experience in clinical trial sample management, biomarker operations, laboratory operations, clinical operations, CRO/vendor management or central/specialty lab coordination

Experience with protocol/lab manual review, sample tracking, data transfer, reconciliation, issue resolution and regulated documentation

Familiarity with China clinical trial environment, HGRAC/CIQ considerations and inspection-readiness expectations

Ability to manage multiple stakeholders, vendors, timelines and issues without direct authority

Strong attention to detail, action tracking, escalation discipline and communication skills