- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology ) studies, support Phase 2/3 studies, represent function ... senior management, and outside vendors.Responsibilities:Responsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and Clinical Pharmacology representativeExternal collaboration: ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and Clinical Pharmacology representative.External collaboration: ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, ... of drug development (eg, nonclinical, pharmacokinetics, biostatistics).Responsibilities:Write critical, complex clinical and clinical pharmacology documents… more
- Daiichi Sankyo, Inc. (Bernards, 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… more
- Daiichi Sankyo, Inc. (Bernards, 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 (Princeton, 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, and combination… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Summary** The 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)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology ) studies, support Phase 2/3 studies, represent function ... and outside vendors. **Responsibilities:** + Responsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … in our Pharmacometrics (PMx) group. The position will report to the Senior Group Director (SGD) within Clinical Pharmacology (CP) in the General Medicine ... a PhD (eg, Pharmacometrics, Biology, Pharmacology , Engineering), PharmD, MD Prior Clinical Pharmacology experience is desired. Does this sound like you?… more
- Sanofi Group (Bridgewater, NJ)
- …Ready to get started? This position is in the Translational Medicine and Clinical Pharmacology department at Sanofi that covers Rare Diseases, Rare Blood ... in designing the early development plan and overall translational medicine and clinical pharmacology plan for the different steps of clinical development +… more
- Merck (Trenton, NJ)
- … Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to ... are seeking an experienced talented scientist to join the **Quantitative Pharmacology and** **Pharmacometrics -** **Immune/Oncology** **(QP2-IO)** team in the role… more
- Sanofi Group (Bridgewater, NJ)
- …with Phase 3 experience being an advantage + Understands and keeps updated with the pre- clinical , clinical pharmacology and data relevant to the molecule of ... what you thought was possible. Ready to get started? The Clinical Research Director (CRD), Dupilumab, Immunology and Inflammation Therapeutic Area is responsible… more
- Sanofi Group (Bridgewater, NJ)
- …development + Demonstrated problem solving skills + Understand and keep updated with the pre- clinical , clinical pharmacology and clinical data relevant ... what you thought was possible. Ready to get started? The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area will be responsible… more
- Bristol Myers Squibb (Princeton, NJ)
- …of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies + Liaises with Clinical ... in their personal lives. Read more: careers.bms.com/working-with-us . The Early Clinical Development function is part of a global scientific organization dedicated… 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)
- …study results as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and Clinical Pharmacology representative. + External ... and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO;… more
- Merck (Trenton, NJ)
- **Job Description** ** Director - Pharmacometrics,** **Quantitative Pharmacology and Pharmacometrics** The Quantitative Pharmacology and Pharmacometrics (QP2) ... decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of… more
