Senior Project Manager

Lawrenceville, New Jersey
April 10, 2026
$55 - $61 / hour
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Job Description

Job Summary:

Precision Medicine, CDX & Design Control Execution:

  • Lead end to end program management for CLIA based diagnostic initiatives, including IUO assay design and development, analytical verification, assay transfer, and CLIA validation.
  • Drive Design Control rigor across design inputs/outputs, risk management, traceability, design reviews, and Design History File (DHF) readiness in alignment with established TM QMS.
  • Partner with Pathology/IHC, Molecular Diagnostics, Device Quality, Regulatory Affairs, and Lab Compliance to ensure compliant and timely clinical enablement.
  • Integrate diagnostic strategies into clinical protocols to support patient stratification and early development decision making.

Bioanalysis Program Management (GLP):

  • Coordinate GLP compliant bioanalytical programs (PK/PD/ADA) supporting clinical studies, including oversight of assay timelines, critical reagents, data transfers, and CRO deliverables.
  • Ensure alignment of bioanalytical execution with IND enabling and clinical milestone expectations, in partnership with Regulatory and QA.
  • Proactively manage interdependencies between diagnostics and bioanalysis where programs require coordinated execution.
  • Provide program management for GLP quality execution, including inspection readiness, audit/inspection coordination, and CAPA governance in partnership with QA and study teams as needed.

Quality, Compliance & Data Integrity:

  • Operationalize QMSR/21 CFR 820, GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11 requirements across laboratory operations, vendors, and data flows.
  • Enforce Good Documentation Practices (GDP) and ALCOA/ALCOA+ principles across sample, method, and data lifecycles.
  • Maintain inspection ready execution through disciplined documentation, validated systems (LIMS/EDMS), and audit ready records.

External Partnerships & Vendor Oversight:

  • Serve as the primary program interface with CROs, CLIA laboratories, IVD/CDx partners, and specialty vendors.
  • Define Products of work, timelines, and deliverables; manage risks, issues, and escalations with a patient impact lens.
  • Ensure vendors meet quality, compliance, and performance expectations.

Program, Portfolio & Financial Management:

  • Build and manage integrated project plans, risks, and dependencies across diagnostics and bioanalysis.
  • Track timelines, forecast resources, and support budget visibility for program leadership.
  • Provide concise, decision focused updates to stakeholders and leadership; escalate risks early with data backed mitigation options.

Ways of Working & Culture:

  • Model Behaviors: Urgency & Agility, Accountability, Innovation, Integrity, and Passion for Excellence.
  • Simplify interface, reduce operational friction, and apply data driven and AI enabled workflows where appropriate to accelerate execution.

Required Qualifications:

  • Bachelor’s degree in a scientific or engineering discipline; MS preferred.
  • 6+ years of experience in GxP regulated environments, spanning Precision Medicine / Diagnostics and/or Bioanalysis.
  • Hands on experience with Design Control execution for IVD/CDX or IUO assays.
  • Strong working knowledge of FDA QMSR (21 CFR 820), GLP, CLIA/CAP, EU IVDR, ISO 13485, and 21 CFR Part 11.
  • Proven ability to lead complex, cross functional programs in matrixed organizations.

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