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Clinical And Health - Sr Project Mgr
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Mindlance
Lawrence Township, NJ (In Person)
Full-Time
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Job Description
Clinical and Health - Sr Project Mgr#26-10114
Lawrenceville, NJ
Onsite Job Description
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 scopes 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 interfaces, reduce operational friction, and apply data driven and AI enabled workflows where appropriate to accelerate execution. Qualifications Required
- 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, EUIVDR, ISO
13485, and 21 CFR Part 11.- Proven ability to lead complex, cross functional programs in matrixed organizations.