- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post ... registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute … more
- Bristol Myers Squibb (Summit, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Pharmacology and Pharmacometrics (CP&P) team at BMS is responsible ... development teams and commercial colleagues to provide input on clinical pharmacology profiling, dose optimization, formulation bridging,...in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+… more
- Merck (Rahway, NJ)
- …**Quantitative Pharmacology and Pharmacometrics -** **Immune/Oncology** team in the role of Associate Director . The team is part of the Global Clinical ... and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs...effective communication skills. As a subject matter expert, the Associate Director within the Group will work… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for ... study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Job Summary:** The Associate Director of Regulatory Writing is a key role responsible for ... study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …of bipolar depression in adults as monotherapy and as adjunctive therapy. The Associate Director / Director of Medical Writing provides support for the ... documents, Regulatory documents, and responses to health authority information requests. The Associate Director / Director of Medical Writing must have… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology , Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …CTD sections for INDs and NDAs, IBs, PIPs, briefing books to support clinical trials and drug registration globally. + Participates in discussions with internal ... experience. + Knowledge of biochemical and mechanistic toxicology, immunology, pharmacology , biology of disease, and/or experimental pathology. Experience designing… more