Clinical And Health - Sr Project Mgr

Clinical and Health - Sr Project Mgr#26-10114 Lawrenceville, NJ All On-site 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, EU

IVDR, ISO

13485, and 21 CFR Part 11.

• Proven ability to lead complex, cross functional programs in matrixed organizations.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."