- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a QSP… 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
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology , clinical operations, non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …immune disorders. **Summary** The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a QSP… 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)
- …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
- AbbVie (Madison, NJ)
- …indications within a Therapeutic Area and support the Manager, Global Regulatory Lead (GRL), Associate Director , or Director , in the development & execution ... contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial. . Responsible… more
