- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead...plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on population PK and PKPD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology ) studies, support Phase 2/3 studies, represent function on study and ... management, and outside vendors.ResponsibilitiesResponsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug development plans,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology ... of QSP within Oncology/Immuno-Oncology. ResponsibilitiesDevelop and apply Quantitative Systems Pharmacology (QSP) models to address drug-discovery and development questionsDevelop… more
- Merck & Co. (Rahway, NJ)
- …We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate ... and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.Associate… more
- Insmed Incorporated (Bridgewater, NJ)
- …project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission ... oligonucleotides, and/or gene therapies is a plus. Advanced knowledge of toxicology, pharmacology , safety pharmacology & DMPK. Comprehensive knowledge of GLP… more
- Merck & Co. (Rahway, NJ)
- …Directors in the Pharmacometrics group within the department of Quantitative Pharmacology and Pharmacometrics (QP2) apply quantitative approaches to develop and ... pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design… more
- Merck & Co. (Boston, MA)
- …determining and implementing the initial clinical strategy through proof-of-concept/ pharmacology / principle and the transition from early to late-stage ... governance.-In addition, the AVP's responsibility will include the clinical pharmacology support of the Common Technical Document (CTD) and label, including relevant… more
- Insmed Incorporated (Bridgewater, NJ)
- …project teams, strategize nonclinical safety data package, oversee safety pharmacology and toxicology studies, author nonclinical sections in regulatory submission ... oligonucleotides, and/or gene therapies is a plus.Advanced knowledge of toxicology, pharmacology , safety pharmacology & DMPK.Comprehensive knowledge of GLP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology , and other departments to strategically manage benefit-risk ... agency or academia, with exposure to drug development, clinical pharmacology , and/or epidemiology requiredDaiichi Sankyo, Inc. is an equal opportunity/affirmative… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …include R&D services for pharmaceutical, chemical, and agricultural industries; pharmacology models and safety assessment; inhalation toxicology; advanced chemical, ... well as working knowledge of histology, clinical pathology, surgery, pharmacology , bacteriology, virology, parasitology, mycology, biochemistry and other related… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …chemistry. Additional competencies within electrical engineering, toxicology and pharmacology are preferred.The position will involve moderately complex work ... assignments as well as documenting laboratory work and maintaining laboratory equipment and supplies. Candidate must also be able to collaborate with research staff, independently conduct testing and review results for accuracy and completeness. Preference… more
- Insmed Incorporated (Bridgewater, NJ)
- …multiple internal and external stakeholders (therapeutic areas, clinical pharmacology , clinical operations, non-clinical safety, contract research organizations ... etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and documentation (lab manual, protocol, report, SAP)Participate in preclinical study design and documentation as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …IRBs and Health Authorities; Collaborates 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:… more
- Merck & Co. (Rahway, NJ)
- …subject matter experts. Contribute to the business development strategy within pharmacology , vaccines, and biologics in conjunction with functional area and clinical ... development leadership. Contribute to the business development strategy within biomarker discovery, clinical trial needs and Companion Diagnostic/Diagnostic programs in conjunction with functional and clinical development leadership. Responsible for leading… more
- Merck & Co. (South San Francisco, CA)
- …management and analytical science to join our Quantitative Biosciences ( Pharmacology ) department.The successful candidate will be accountable for maintaining the ... department compound inventory, implementing a robust compound management workflow using lab automation, fulfilling compound requests, and performing quality control to maintain accuracy and integrity. In addition, this individual will also contribute to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 reference list for study.Study Planning: Contributes to clinical trial… more
- Aequor (South San Francisco, CA)
- …immuno-oncology programs. You will be responsible for generating and communicating pharmacology data to support the progression of oncology and immunotherapy ... research programs. Designing, conducting, analyzing, and reporting in vivo and in vitro studies. In vivo work will include handling techniques, such as, tumor inoculation and measurement, Oral, SC, RO, IP and IV dosing, blood, tissue collection and model… more
- Aequor (Thousand Oaks, CA)
- …of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology , Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing ... documents, and safety narratives Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications) Lead study timelines for regulatory documents and regulatory submission strategy Act as a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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.Develop a strong, positive strategic business partnership with the global R&D business functions of Daiichi Sankyo. As a trusted… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required.-7 or more years of experience within pharmacovigilance, clinical pharmacology , preclinical research, toxicology and/or biomarker validation (especially in ... industry) required. TravelMust have the ability to travel up to 10% domestic and internationalDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender… more
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