- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in and contribute to regulatory and KOL meetings. This position requires significant understanding of PK - PD and Pop PK - PD concepts and analysis, phase ... independent writing for publications and regulatory documentsServes as a specialist in PK - PD and Pop PK - PD concepts and independently performs… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project teamsProduces independent writing for publications & regulatory documentsServes as a specialist in PK - PD and Pop PK - PD concepts, phase 1-4 ... clinical studies, literature, and regulatory guidelines and can conduct/develop PK - PD and Pop PK - PD analyses,Participates in KOL and regulatory… more
- Merck & Co. (Rahway, NJ)
- …questions for optimizing model-informed development-Responsible for developing and executing population pharmacokinetic models, PK / PD models, ER models, ... of the following pharmacometrics capabilities such as population pharmacokinetics (popPK), PK / PD models, exposure response (ER) models, model-based meta-analysis… more
- Insmed Incorporated (Bridgewater, NJ)
- …clinical pharmacology support to late phase clinical studies Plan, perform, and/or oversee PK , PK / PD and pharmacometric analyses for clinical and ... with clinical pharmacology related regulatory guidelines.Hands-on and Working knowledge of population PK , PBPK, PK / PD modeling are highly desirable.Hands-on… more
- Merck & Co. (Rahway, NJ)
- …analyses on programs.Developing and executing model-based analyses including translational PK / PD approaches, population pharmacokinetic models, ... Pharmacometrics - Immune/Oncology team in the role of Associate Director . The team is part of the Global Clinical...communication skills. As a subject matter expert, the Associate Director within the Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary The purpose of this position is to analyze single Population PK / PD Phase 1 to 3 studies, simulate multiple dose scenarios, and write ... demonstrates general knowledge of Phase 1 studies and multiple dose scenarios, PK / PD M&S analysis data structures and analysis tools requirements, simple disease… more
- Catalent (St. Petersburg, FL)
- …out required pre-formulation, formulation and process activities. The Associate Scientist III, PD and the Product Development team is responsible for new product ... pre-formulation, formulation preparation, testing and analysis work in the PD lab. Schedule and conduct lab work to ensure...batch records, reports and logbooks. Prepare samples for animal PK studies. Provide training to new or existing personnel.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responses to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads ... Leads broad collaboration with KOLs or major institution, eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development… more
- Merck & Co. (North Wales, PA)
- …Statistics, Clinical Research, Regulatory, Observational Research, Clinical Safety and PK / PD Modeling and Simulation organizations.Primary Activities :Address ... operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide.Lead development of therapeutic areas- specific standard Tables, Listings, Figures (TLF) libraries-Facilitate global… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to IRBs and HA, Collaborates with Translational Medicine to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …through lentivirus vector design, in vitro function assay, and assay development of virus PK and PD in animal model. 1-3 year biotech or pharmaceutical industry ... experience is preferredbut not required. The candidate needs to demonstrate the ability of delivering scientific results with integrity and meeting timeline, show the value of collaboration and teamwork, and provide strategy, expertise, resources and guidance… more
- Lilly (Indianapolis, IN)
- …small molecules, peptides, antibodies, genetic medicines, RNA therapeutics and more. The PK / PD organization applies a variety of model-based approaches including ... PBPK, PK / PD , QSP and pharmacometrics to impact across...analytical and computational tools to characterize factors influencing the pharmacokinetic and pharmacodynamic properties of our drugs.… more
- Lilly (Indianapolis, IN)
- …projects. Your work will contribute to the development of physiologically-based pharmacokinetic / pharmacodynamic (PBPK/ PD ) models for antibody-drug conjugates ... people around the world. **About Eli Lilly's Postdoctoral Scientist Program ** When it comes to research and development, our... pharmacodynamic principles + Experience in PBPK, QSP, PK / PD , exposure-response modeling or other modeling &… more
- IQVIA (New Haven, CT)
- …a highly skilled and motivated Principal Statistical Programmer with expertise in pharmacokinetics ( PK ) and pharmacodynamics ( PD ) to join our dynamic FSP team. ... Position Overview: As a Principal Statistical Programmer with a specialized focus on PK / PD , you will play a pivotal role in the design, execution, and analysis… more
- ThermoFisher Scientific (Richmond, VA)
- …is responsible for leading all aspects of the analysis and interpretation of the Pharmacokinetic / Pharmacodynamic ( PK / PD ) aspects of clinical trials ... Clinical pharmacology provides the support vital to elucidate the pharmacokinetics and PK / PD relationships in support of our client's drug development efforts.… more
- Bausch Health (Bridgewater, NJ)
- …manager will support the design, execution, interpretation and reporting of clinical pharmacokinetic / pharmacodynamic ( PK / PD ) studies. + The individual ... for regulatory filings along with analysis and presentation of PK / PD data to internal teams. + Experience...3+ years, BS with 5+ years of experience in Pharmacokinetic / Pharmacodynamic / Clinical Pharmacology Benefits package includes… more
- Sanofi Group (Cambridge, MA)
- …effective therapeutic treatment of each patient by applying appropriate pharmacokinetic ( PK ) and pharmacodynamic ( PD ) principles to drug development and ... where possible. PKDM generates, integrates, and leverages clinical and non-clinical PK , PK / PD and metabolism knowledge to support critical decision making… more
- Amgen (South San Francisco, CA)
- …Clinical Pharmacology approaches to guide optimal drug development including Pharmacokinetic / Pharmacodynamic ( PK / PD ) modeling, ... Mechanistic-Physiologically Based Pharmacokinetic (M-PBPK) modeling, Mechanistic-PBPK- Pharmacodynamic (M-PBPK- PD ) modeling and Quantitative Systems Pharmacology… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …multiple programs. The person in this role is responsible for the execution of PK , PD , and other types of quantitative analyses that significantly contribute to ... apply standardized scientific techniques to analyze in-vivo and in-vitro pharmacokinetic & pharmacodynamic studies. We need this...variety PMx studies.* Performing a broad array of quantitative PK or PK / PD analyses such… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …, Clinical Pharmacology works to advance multiple compounds by integrating PK / PD and clinical data to evaluate/simulate optimal doses/regimens, ... explaining/defending the PK strategy and data analyses, and providing PK deliverables according to timelines. The Senior Director , Clinical Pharmacology… more
