- Merck & Co. (North Wales, PA)
- …programming expertise with clinical endpoint data (efficacy and safety) and pharmacokinetic data (raw concentration data, derived PK parameters).Preferred Skills ... high quality statistical programming analysis and reporting deliverables for global PK modeling and simulation stakeholders spanning all of our company's therapeutic… more
- Merck & Co. (Rahway, NJ)
- …for optimizing model-informed development-Responsible for developing and executing population pharmacokinetic models, PK /PD models, ER models, MBMA, CTS, ... the following pharmacometrics capabilities such as population pharmacokinetics (popPK), PK /PD models, exposure response (ER) models, model-based meta-analysis (MBMA),… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …contribute to regulatory and KOL meetings. This position requires significant understanding of PK -PD and Pop PK -PD concepts and analysis, phase 1-4 clinical ... writing for publications and regulatory documentsServes as a specialist in PK -PD and Pop PK -PD concepts and independently performs PK -PD analyses, functions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD analyses and participate in regulatory interactions and submissions ... for publications & regulatory documentsServes as a specialist in PK -PD and Pop PK -PD concepts, phase 1-4 clinical studies, literature, and regulatory guidelines… more
- Merck & Co. (Rahway, NJ)
- …on programs.Developing and executing model-based analyses including translational PK /PD approaches, population pharmacokinetic models, exposure-response models, ... clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.Strategizing… more
- Merck & Co. (Rahway, NJ)
- …in decision making and driving pipeline impact: population pharmacokinetics ( PK ) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial ... engineering, or a related field Extensive experience in performing population PK and PK /PD analyses using standard pharmacometrics software (eg,… more
- Option Care Health (Dublin, OH)
- …maintaining relationships within a team.Experience applying knowledge in pharmacokinetic principles and formulas, and assessing laboratory values.Experience applying ... knowledge in basic patient management skills, clinical procedures and clinical documentation systems.Knowledge of rules of Federal, state and local regulatory entities that oversee and control the provision and documentation of home health care services.… more
- BioAgilytix (Durham, NC)
- …leading the development and validation of Anti-drug Antibodies (ADA) and Pharmacokinetics ( PK ) assays, playing a vital role in bringing innovative therapies to ... of GxP regulations IA role: Experience with execution of PK /biomarker/ADA assaysCB role: Experience with execution of potency/NAb assaysWorking Environment:Primarily… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …Service to provide the customer with quality pharmaceutical care. Demonstrate basic pharmacokinetic skills and is capable of applying these principles to clinical ... obtained. Also, communicate effectively with nurses and other members of the Pharmacokinetic Service to ensure quality management of our patients. Maintains NGMC's… more
- Insmed Incorporated (Bridgewater, NJ)
- …validations and sample analysis from early to late development for pharmacokinetic and biomarkers studies.Accountable for the scientific guidance and design of ... the bioanalytical translational and clinical strategies and the execution (eg Biomarker) of therapeutic programs with different modalities.Assure bioanalytical tasks are executed to high scientific standards, with quality, and within agreed timelines. This… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation ... meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality check of data, Works with BDO to ensure SAP updates; Responsible for valid clinical interpretation of study results as Clinical Study Leader, medical monitor or… more
- Merck & Co. (North Wales, PA)
- …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 adoption of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and HA, Collaborates with Translational Medicine to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads ... dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality check of data, Works with BD&O to ensure SAP updates; Interact with Key External Experts (KEEs) to validate interpretation of study results; Present… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development of study design to meet study objectives, development of biomarker/ PK strategy in collaboration with Translational Medicine and Clinical Pharmacology ... (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …standards.Is accountable for quality delivery of diverse external data (ex: Central Labs, PK , ADA, Biomarker, Genomic, CDx, etc.) for DS Programs / Studies operating ... under the outsourced and in-house operating models.Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements.Supports any external data… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …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 in a… more
- Merck & Co. (Rahway, NJ)
- …a variety of external data types (ie, genetics, immunogenicity, PK /PD).Understanding of collection and terminology associated with questionnaires.Understanding of ... lab values and the importance and maintenance of unit of measure conversions.Knowledge of versioning and maintenance of controlled terminology.Excellent communication/presentation skills.Must have an innovative spirit, outstanding interpersonal skills,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads ... dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works with BD&O to ensure SAP updateExternal collaboration: Consults with internal experts and external… more
- BioAgilytix (Boston, MA)
- …regulatory guidance and industry best practices for Biomarker and/or PK assaysAdvanced capabilities in data analysis, data visualization statistical ... analysisLigand-binding Assay (eg ELISA, MSD, Luminex) assay development and validationMicrosoft Office, MSD workbench, SoftMAX Pro, Watson, Graphpad Prism,Experience or familiarity working in a regulated environment; GDP, GLP, GCLP, GCPA talent for designing… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation ... meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality check of data, Works with BDO to ensure SAP updates; Interact with Key Opinion Leaders (KOLs) to validate interpretation of study results; Present results to… more
Related Job Searches:
Analyst ADA PK 1,
PK Modeling,
PK PhD,
Pk/pd,
Research Associate PK,
Research Scientist PK PD,
Scientist ADA PK 1,
Scientist ADA PK 2,
Scientist PK PD Biologics,
Scientist/sr PK