Associate Director, Project Management & Operations – (Translational Medicine, CLIA, & Bioanalysis)
Core
Leads program management and operational framework for BMS's internal CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs, enabling internal/external bioanalysis studies and supporting assay development/validation for early-stage Phase I/II patient stratification.
Role type
Associate Director, Project Management & Operations (Regulated Laboratory & Bioanalysis)
Builds
Internal BMS CLIA laboratory and Bioanalysis Biotherapeutics & Cell Therapy programs, investigational biomarker assays, and early-stage Phase I/II patient stratification studies.
Domain
Biotechnology / Regulated Laboratory Operations / Bioanalysis
Required skills
Systems engineering, Design control, Project management, Risk management, Budget management, Vendor management, Regulatory compliance, Cross-functional leadership, Financial acumen, Operational rigor
Preferred skills
MS or Ph.D., PMP certification, IVD device development experience, IHC/molecular diagnostic technology experience
Technologies
Microsoft Project, SAP, Ariba, LIMS, Visio, Teams
Responsibilities
Lead process for assay design, development, validation, and technology transfer; Drive design control practices across the assay lifecycle; Lead project management for internal IHC and molecular IUO assay programs; Own program planning, timelines, and CapEx/OpEx budgets; Partner with cross-functional teams to ensure alignment with clinical protocols and regulatory requirements; Lead third-party risk management and supplier quality management for external vendors; Strengthen program compliance and lead inspection readiness; Represent PM&O on governance committees; Own systems and reporting for laboratory operational metrics; Proactively identify and mitigate operational and compliance risks.
Seniority
Senior, hands-on IC with strategic oversight
