- Merck & Co. (Rahway, NJ)
- … development teams and the operational/executional arms within the business. The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary ... Clinical Research, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Drug Development, Good Manufacturing Practices (GMP), Inventory Control System,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Associate Director, External Data Quality Management, is a strategic leadership role within ... Clinical Data Management. This individual is accountable for driving...for inspection readiness, regulatory compliance, and successful data submissions.The Associate Director will lead cross-functional collaboration, provide oversight of… more
- ACROBiosystems Inc. (Seattle, WA)
- …in developing and manufacturing recombinant proteins and critical reagents/assays to support drug development and clinical applications from target discovery and ... drug screening and optimization, CMC development, preclinical and clinical studies, commercial production, and companion diagnostics. We are committed to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery ... of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure… more
- Genmab (NJ)
- …across an increasingly complex matrix environment. Strong understanding of all aspects of clinical drug development, with particular emphasis on clinical ... competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.Key contributor to the study's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. Drug Development Strategy: Provides input ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... records, forms, and support and manage change controls.Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Associate Manager , Clinical Drug Supply & Logistics provides support for and may be responsible for forecasting Investigational Product (IP) supply ... Includes:** + Serves as lead drug supply manager of multiple small and/or less complex clinical...compliant shipment and delivery to investigator sites. Works with Clinical Logistics Associate to complete this activity… more
- Sumitomo Pharma (Phoenix, AZ)
- …We are currently seeking a versatile and experienced Senior Manager - Associate Director level scientist with strengths in clinical pharmacology, and a ... brochures (IB), new drug application (NDA) common technical document (CTD) non- clinical drug metabolism, bioanalytic, and clinical pharmacology chapters,… more
