- Aequor (South San Francisco, CA)
- …Pharmacokinetics and Pharmacodynamics (PTPK). (S)He will be part of the PK technology/operations group and will be supporting the larger PTPK department ... in their execution of PK studies of molecule characterization as well as preclinical...as well as preclinical models development to determine the PK and metabolic fate of our candidate therapeutics. The… 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
- Insmed Incorporated (Bridgewater, NJ)
- …and accountable for designing clinical pharmacology programs and studies, performing PK and PKPD data analysis, supporting clinical dose selection and authoring ... pharmacology support to late phase clinical studies Plan, perform, and/or oversee PK , PK /PD and pharmacometric analyses for clinical and non-clinical… 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
- Piper Companies (Pipersville, PA)
- …of all project schedulers in the company in the Polyclonal, Monoclonal and Pharmacokinetic studies. Write and revise SOPs and Batch Records as needed.. Attending ... quality systems and manufacturing operations. . Hands on experience with different PK and Toxicology Techniques and Studies Compensation & Benefits for the Scientist… more
- BioAgilytix (Durham, NC)
- …individual to join our dynamic team as a an Analyst I/II supporting immunoassay (ADA/ PK ) development. As a key member of our innovative research team, you will play ... buffers.Ability to carry out routine tasks accurately, following strict immunoassay (ADA/ PK ) methodology to carry out analysis, preparing samples and maintaining and… more
- BioAgilytix (Durham, NC)
- …understanding of laboratory workflows, processes, and instrumentation; Experience with pharmacokinetic , anti-drug antibody and PCR assays is preferred. Experience ... with a variety of laboratory automation technologies, including liquid handlers, robotic arms, and automated assay platforms.Familiarity with regulatory requirements for laboratory operations, including GLP and GMP.Exceptional communication skills, with the… 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
- Eisai, Inc (Nutley, NJ)
- …different types of external clinical data transfers eg, laboratory data, PK , ECG,Tumor. Participate in system validation, customization, and integration of new ... tools and technologies. Requires: Bachelor's degree or foreign equivalent in Computer Science, Technology, Electronics and Communication Engineering, or Business Intelligence and Analytics plus 2 years of work experience in job offered or as Senior Systems… 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
- 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)
- …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
- 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
- Lilly (Indianapolis, IN)
- …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 this portfolio...analytical and computational tools to characterize factors influencing the pharmacokinetic and pharmacodynamic properties of our drugs. We need… more
- Lilly (Indianapolis, IN)
- …Your work will contribute to the development of physiologically-based pharmacokinetic /pharmacodynamic (PBPK/PD) models for antibody-drug conjugates (ADCs). In this ... + Working environment - primary mentors in small and large molecule PK /PD, collaboration with relevant functions across the organization **Basic Qualifications** +… 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