- Gilead Sciences, Inc. (Parsippany, NJ)
- …fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Clinical Pharmacology - Virology** ... Jersey_** **POSITION OVERVIEW:** With considerable independence, you will typically lead clinical pharmacology studies of increasing complexity in Virology… 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
- 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
- AbbVie (Florham Park, NJ)
- …leads those efforts. Anticipates and critically evaluates Statistical, PK/PD, Clinical Pharmacology , or regulatory advances, strengths, weaknesses, opportunities ... for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management. Responsibilities: + Executes… more
- AbbVie (Branchburg, NJ)
- …products and during due diligence activities. Responsibilities: *Understand and apply pharmacology , chemistry and non- clinical toxicology to effectively conduct ... supporting Product Safety Leads (PSTs) to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for… 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. The Tech Lead must have the ability to develop a strong, positive strategic business… more