- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development organization will ... provide leadership and expertise to support assigned clinical pharmacology projects in the clinical development programs for an expanding portfolio of small,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disabilities.SummaryThe 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 study teams to execute… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology ) studies, support Phase 2/3 studies, represent function ... senior management, and outside vendors.ResponsibilitiesResponsible for all aspects of Clinical Pharmacology and Biopharmaceutics studies and model-based drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative Clinical Pharmacology (QCP) group to develop and apply QSP models to ... which include target prioritization, therapeutic modality selection, biomarker characterization and clinical trial design. In addition, he/she will develop a QSP… more
- Merck & Co. (Rahway, NJ)
- …organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical ... modelling approaches, such as population pharmacokinetic, exposure-response, quantitative system pharmacology , and other model-based analyses.-Perform clinical trial… 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 ... clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology , and/or epidemiology requiredDaiichi Sankyo, Inc. is an ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology , and other… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… 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 ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position has extensive knowledge of regulated BA, DMPK, biological sciences, clinical pharmacology , BA strategic planning, regulatory guidance, and in-licensing ... head of regulated bioanalysis will also form strategic internal (DMPRL, Clinical Operations, Data Management, Scientific Operations etc) and external partnerships to… more
- Merck & Co. (Boston, MA)
- …early to late-stage governance.-In addition, the AVP's responsibility will include the clinical pharmacology support of the Common Technical Document (CTD) and ... for Immunology assets.Conduct DRC reviews. (protocols, strategy, other)Sign off on clinical pharmacology CTD submissions and NDAs.Regular updates with key… more
- Merck & Co. (Rahway, NJ)
- …transition from early to late-stage governance.-In addition, responsibility will include the clinical pharmacology support of the Common Technical Document (CTD) ... assets Conduct DRC reviews (protocols, strategy, other) Sign off on clinical pharmacology CTD submissions and NDAs Regular updates with key cross-functional… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …areas within R&D (including clinical operations, data management, biostatistics, clinical pharmacology , preclinical) to facilitate the execution of ... and follow @JazzPharma on Twitter. Brief Description:Jazz Pharmaceuticals is seeking a clinical development physician to join a team in hematology oncology drug… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …geographies.Cross-functional Collaboration: Collaborate closely with cross-functional teams, including clinical pharmacology , translational medicine, clinical ... visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Clinical Development Lead, Oncology, BTC (Biliary Tract Cancer) and GEA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in pharmacology or pharmaceutical sciences or PharmD with a clinical pharmacology research fellowship required Experience Qualifications 1+ years Industry ... Experience required1+ years' experience with the following systems: NONMEM, R, PsN, XPose, WinNONLIN (Phoenix), WinBUGS, MONOLIX required Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …local cross-functional study teams, including personnel from Medical & Science, Clinical Pharmacology , Biostatistics, Clinical Operations, Regulatory ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Insmed Incorporated (Bridgewater, NJ)
- …related issues.Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology , clinical operations, non- clinical ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Development, 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… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …Phase I and Phase II oncology study design experience.Knowledge of clinical pharmacology and translational science preferred.Experience in contributing to ... the planning, conduct, and analysis of early phase oncology clinical studies. Oversees professional development of biostatisticians.Essential FunctionsLead early… more
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