Strategic and innovative Biopharmaceutical Research Manager with experience in product development of in vitro diagnostics and pharmaceuticals across Immunology and Oncology therapeutic areas. Demonstrated success engaging teams and building cohesion to support clinical trials for drug and companion diagnostics (CDx) development through coaching, collaboration, quality and process improvement.  Experienced in compliance with GCLP, GLP, HIPAA, CLIA, ICH and GCP. Core competencies include: • Clinical Trial Specialty Lab Support • Diagnostics Lab Regulatory Compliance • Project and Program Management • Audit Readiness • Process Improvement • Diagnostics Molecular Assay Development • CLIA Assay Validation • Principal Investigator Role • SOW / Services Agreement Negotiation • Biopharmaceutical Services Management