APAC diagnostic project manager (contractor)

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Manager/Senior Manager APAC Diagnostic Project Management Lead (PML) Oncology Precision Medicine & Diagnostics (O-PMDx)

Location: Shanghai China

Employment Type: Full-time Contractor

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The APAC Diagnostic Project Management Lead (PML) Oncology Precision Medicine & Diagnostics (O-PMDx) is responsible for managing diagnostic programs across the Asia Pacific region.

The role partners closely with APAC Diagnostic Leads to facilitate cross-functional alignment across Clinical Development Global Diagnostics Development teams Regulatory Affairs Commercial organizations external laboratories and diagnostic partners ensuring the successful execution of biomarker patient selection and companion diagnostic (CDx) strategies that support oncology drug development and lifecycle management.

The individual is accountable for integrated project planning milestone management risk mitigation budget oversight stakeholder alignment and operational excellence across a portfolio of oncology diagnostic programs.

This position is based in Shanghai and reports directly to the APAC Solid Tumor Diagnostics Lead O-PMDx.

Key Responsibilities

Project Leadership & Execution

• Lead end-to-end project management of APAC diagnostic and biomarker initiatives.
• Develop and maintain integrated project plans timelines budgets resource forecasts and risk management plans.
• Drive critical path activities and ensure milestone delivery on time and within scope.
• Identify assess and proactively mitigate project risks and issues.

Cross-functional Leadership

• Coordinate activities across Precision Medicine Clinical Development Regulatory Affairs Medical Affairs Commercial Strategy Biomarker & Diagnostic Operations and Informatics functions.
• Ensure alignment between regional and global stakeholders regarding diagnostic strategies and execution plans.
• Facilitate governance meetings and maintain project documentation including action logs decision logs and risk registers.
• Influence cross-functional teams without direct reporting authority.

Diagnostic Program Management

• Support implementation of patient selection assays for clinical trials and companion diagnostic development programs.
• Coordinate external diagnostic partners central laboratories CROs and Joint Project Teams (JPTs).
• Support regional diagnostic regulatory submissions and launch readiness activities.
• Contribute to APAC diagnostic strategy development and portfolio planning.

Portfolio & Operational Excellence

• Monitor project budgets financial forecasts and portfolio performance metrics.
• Provide scenario planning project updates and recommendations to leadership.
• Drive continuous improvement of project management processes tools and best practices.
• Support strategic initiatives across the APAC O-PMDx organization.

Qualifications

Required

• Ph.D. or Masters degree in Life Sciences or a related discipline.
• Minimum 810 years of experience in pharmaceutical biotechnology diagnostics or clinical research environments.
• Strong understanding of clinical trial design and execution including efficacy endpoints biomarker testing sample operations data management and biospecimen management.
• Knowledge of diagnostic and biomarker development including analytical validation clinical validation and companion diagnostic development processes.
• Understanding of LDT RUO and IVD development pathways and associated regulatory requirements.
• Familiarity with GCP GCLP CLIA CAP and ISO15189 laboratory standards.
• Broad understanding of diagnostic and biomarker technologies including PCR NGS IHC immunoassays liquid biopsy digital pathology and multiplex platforms.
• Strong stakeholder management and influencing skills.
• Proven ability to lead cross-functional teams in a matrix environment.
• Strong strategic thinking problem-solving and decision-making capabilities.
• Excellent written and verbal communication skills in English and Chinese.

Preferred

• Oncology experience.
• Experience supporting CDx biomarker or precision medicine programs in oncology drug development.
• Experience supporting CDx or IVD product development and regulatory submissions.
• Experience working with NMPA PMDA or other global health authorities.
• Experience overseeing biomarker assay transfers validations and implementation at CROs or clinical laboratories.
• Experience managing complex multi-disciplinary development programs within a matrix organization.
• Proficiency in Japanese is a plus.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin or protected veteran status and will not be discriminated against on the basis of disability.

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