- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical ... disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase 2/3 ... drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology ) studies, support Phase 2/3 studies, represent function… more
- Merck & Co. (Rahway, NJ)
- … Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to ... Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder Relationship ManagementPreferred… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management , Biostatistics, Pharmacology , and other departments to ... industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology , and/or epidemiology requiredDaiichi Sankyo, Inc. is an… 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 ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the… more
- Insmed Incorporated (Bridgewater, NJ)
- … teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... safety studies outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact… more
- Insmed Incorporated (Bridgewater, NJ)
- … teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... safety studies outsourced to contract research organizations.Provide strategic input to project teams and senior management regarding the potential impact… more
- Merck & Co. (Rahway, NJ)
- …registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to ... Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management , Software Development, Stakeholder Relationship ManagementPreferred… more
- Aequor (Thousand Oaks, CA)
- …Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology , Summary of Biopharmaceutics, ... principles, concepts, theories, and standards of scientific/technical field Strong time and project management skills, engaging approach, and perseverance with a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, Quantitative Clinical Pharmacology , Clinical ... , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services Project Management and Operational Management .Develop a strong,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …here required.-7 or more years of experience within pharmacovigilance, clinical pharmacology , preclinical research, toxicology and/or biomarker validation ... for accelerated development and approval with smaller numbers of subjects exposed, Clinical Safety and Pharmacovigilance (CSPV) must be embedded in R&D as early… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …and contracts. Life science or preclinical research experience along with successful project management , client support, sales, territory management or ... stewarding and securing business opportunities in chemistry, bioanalysis, toxicology, pharmacology , medicinal chemistry, ADME/PK, program management services,… more
- DivIHN Integration Inc (Green Oaks, IL)
- …The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by ... requirements. Monitor applications under regulatory review. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies. Assist… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …biosample-related departments/groups such as Scientific Operations (SciOps), project management , quantitative clinical pharmacology (QCP), translational ... biosample-related activities globally, including collection, handling, storage, disposal, transfers, and project management for analyses. The BSM leader will… more
- AbbVie (North Chicago, IL)
- …for critically evaluating technical, scientific aspects of all AbbVie projects along with CLINICAL PHARMACOLOGY management . Reviews clinical protocols ... will be expected to communicate/present and lead key Clinical Pharmacology information/strategy to senior and executive management , regulatory agencies, and… more
- BeiGene (San Mateo, CA)
- …excellent. **Essential Functions of the job:** + Actively participate as the functional clinical pharmacology representative on project teams. + Develop and ... + Analyze, interpret, summarize, and present data to internal project teams, senior management , and to global...the group as needed + Manage clinical pharmacology vendors, and consultants for specific project … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical ... **Summary** The Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to… more
- Takeda Pharmaceuticals (Boston, MA)
- …project goals. + This individual will contribute to the clinical pharmacology and pharmacometrics strategy to support PDT project progression from entry ... to the best of my knowledge. **Job Description** **Director, Clinical Pharmacology ** **Cambridge, MA** **_OBJECTIVES/PURPOSE_** The PDT...to clinical development to life cycle management + This individual will act as the global… more
- Teva Pharmaceuticals (West Chester, PA)
- Director Clinical Pharmacology Date: Mar 26, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva Pharmaceuticals Job Id: 54853 **Who we ... people to make a difference with. **The opportunity** This Clinical Pharmacology role is part of the...(CP) will represent the CP department at internal (study, project , clinical team) and external meetings (with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …direct impact. Join Gilead and help create possible, together. **Job Description** **Director, Clinical Pharmacology - Virology** **_** this role is site based ... in Foster City, CA_** As a Director within the Clinical Pharmacology Group at Gilead, you will have significant responsibility and accountability for clinical… more
