Diagnostic Lead (Contract)

Science / Laboratory / Research & Development • Contract / Project Based • Hong Kong, Hong Kong, HK • 1w ago

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong to Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

About the job

Astellas is seeking a Contract Diagnostic Lead to accelerate the clinical adoption, accessibility, and quality of biomarker testing across priority institutions and networks. The role will partner with pathologists, laboratories, oncologists, hospital administrators, and diagnostic companies to establish pragmatic pathways for testing, enable high-quality and timely turnaround, and align testing practices with clinical use. The successful candidate will bridge technical diagnostics with clinical implementation, ensuring patient identification scales ethically and compliantly.

Key Responsibilities

Strategy & Planning

Develop and execute testing adoption plans for priority centers, including baseline mapping, uplift strategy, and monthly milestones.
Define preferred testing modalities and quality standards (controls, scoring criteria, cut-offs, inter-observer reproducibility).
Build a center-level segmentation model (capacity, readiness, volumes, turnaround time, quality indicators) and prioritize interventions accordingly.

External Stakeholder Engagement

Partner with department heads and pathologists to adopt validated assays/workflows; support concordance exercises and pathologist education.
Engage laboratory directors to optimize pre-analytic variables (fixation time, specimen handling), analytic steps (validated antibody clones, platforms, LDT vs. IVD), and post-analytic reporting (standardized templates).
Coordinate with diagnostic partners (IHC platform providers, CDx partners, reference labs) on assay onboarding, validations, and training.
Support oncologist engagement on test ordering triggers, reflex testing policies, and integration into tumor boards and care pathways.

Implementation & Operations

Drive assay validation plans (accuracy, precision, sensitivity/specificity, reproducibility) with lab partners; facilitate inter-lab concordance where needed.
Standardize reporting templates (biomarker status, scoring system, cut-off, clone/platform, controls, pathologist signature, interpretation notes).
Enable reflex testing workflows for eligible tumor types (e.g., gastric/GEJ adenocarcinoma) and alignment with biopsy/surgical pathology SOPs.
Monitor turnaround times, testing utilization and referral dynamics; work with laboratories to resolve operational challenges.
Establish data capture dashboards (de-identified) for test volumes, positivity rates, and trends to inform education needs.

Education & Evidence Generation

Plan and deliver educational programs for pathologists (grand rounds, case-based workshops, interobserver calibration sessions).
Curate and disseminate a testing toolkit (SOP highlights, antibody clone guidance, scoring atlas, QC checklist).
Support testing-related publications/abstracts or local consensus statements (non-promotional, evidence-based) in collaboration with medical and scientific leaders.

Governance & Compliance

Ensure all activities comply with local regulations, Astellas policies, and ethical guidelines.
Work cross-functionally with Medical, Regulatory, Legal/Compliance, Market Access, and Commercial (as appropriate) to align on non-promotional, patient-centric implementation.
Maintain transparent documentation of interactions, materials, and decisions.

Requirements

Bachelor’s or Master’s Degree or PhD in Pathology / Life Sciences / Medical Laboratory Science, Healthcare or related field
2+ years of experience in diagnostics ; experience in oncology diagnostics is highly preferred.
Scientific knowledge of testing platforms, antibody clone selection, biomarker validation, application, and quality systems.
Strong track record in clinical implementation projects in hospital labs, familiarity with healthcare system operations in Hong Kong.
Excellent stakeholder management with pathologists, lab directors, oncologists, and diagnostic vendors.
Good communication, interpersonal, cross-functional abilities, data literacy (Excel/ dashboards) for monitoring volumes, TAT, and positivity rates.
Fluent in Cantonese, English, Mandarin.

"Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help”

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