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Senior Project Manager
Job Description
• 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.
Pay Rate Range: $55.00 - $61.00/hr/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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