- Taiho Oncology (Princeton, NJ)
- …to transforming the landscape of cancer treatment and improving patients' lives. As a Senior Director , Biomarkers and CDx Development, you will play a pivotal ... Sr . Director , Biomarker & Companion Diagnostic...companion diagnostic/assay development. + Extensive knowledge of the oncology drug development and device development process in… more
- Merck (West Point, PA)
- …Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe ... and launches. **Principal Responsibilities** + Lead and set direction for the device development strategy for multiple drug - device combination product… more
- Novo Nordisk (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Strategy Director is a senior individual contributor role, and the job function requires a ... to improve working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for...of patients' needs in line with the 5D aspiration ( Drug , Device , Diagnostic tool, Digital solution, and… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development and ... + Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions. + Understands and interprets… more
- Integra LifeSciences (Princeton, NJ)
- …and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical ... patient outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Director , Supplier Controls is the Compliance Master Plan (CMP) Quality Management System… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …the Company-wide patient safety expert for assigned pharmaceutical / biological / drug - device combined products, accountable for the safety strategy and major ... that may impact the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation, review, and… more