- Merck & Co. (North Wales, PA)
- …arrangement and requires daily in-office presence.KEY RESPONSIBILITIES:Identify asset-specific translational deliverables & gaps.- Building testable hypothesis & ... strategy: collaborate across different LFs, to formulate testable clinical and translational hypotheses; and develop clinical biomarker and translational … more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational Medicine, will be responsible for leading the Translational ... role in overseeing the scientific direction of clinical programs involving Translational Immunology.-They are expected to operate in a highly collaborative and… more
- Merck & Co. (Rahway, NJ)
- …Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and strategy, bridging ... role in overseeing the scientific direction of clinical programs involving translational research and early clinical development for the Cardiovascular & Respiratory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …embedded in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi ... are poorly defined or undefined. Mentor junior CSPV physician staff on translational safety topics. Grow and maintain connections with external safety experts… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role ... bioanalytical assays for clinical, nonclinical and biomarkers studies. This translational role resides within the Clinical Development organization, works closely… more
- Merck & Co. (Boston, MA)
- …contributing to development, execution, and fostering of translational pharmacokinetic-pharmacodynamic/efficacy relationships and other useful quantitative ... project-team leadership contributing to development, execution, and fostering of translational pharmacokinetic/pharmacodynamic/efficacy relationships for protein therapeuticsTechnical ability to analyze,… more
- Merck & Co. (North Wales, PA)
- …analysis of Phase I/II oncology clinical trials as well as translational biomarker analyses. This position requires strong communication skills, interpersonal skills ... clinical oncology programs as well as statistical support for translational oncology projects and studies.-Interact with Clinical, Regulatory, Statistical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency with study strategy, Develops biomarker strategy in collaboration with Translational Medicine, Collaborates with external KEEs to refine study plans; ... Phase 3 studies: Drafts responses to IRBs and HA, Collaborates with Translational Medicine to ensure appropriate biomarker, PK / PD measurements, Reviews emerging… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study ... outputs: Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK /… more
- Aequor (San Diego, CA)
- …(eg Clinical Operations, Regulatory Affairs, Biometrics, Drug Safety, Translational Medicine, Clinical Development). Strong consultative approach with ability ... to demonstrate positive relationship building with various stakeholders (Candidates, Hiring Managers, HR Business Partners, Executive Leadership, Vendors, etc.). Experience researching, developing, and implementing new candidate sourcing and search methods.… more
- Aequor (South San Francisco, CA)
- Position & Duties: A temp/contractor position in Translational Immunology (in vivo immunology research group). Responsibilities are primarily carrying out animal ... research studies, including monitoring, dosing, and animal necropsy and organ collection. Primarily in mice, with occasional work in rats and guinea pigs. The individual may need to work with infectious and/or bio-hazardous reagents and material. The… more
- Merck & Co. (Rahway, NJ)
- …responsibilities including:Applying quantitative approaches to develop and implement translational clinical pharmacokinetics and pharmacodynamics of new chemical ... entities and biologicsDeveloping and executing pharmacokinetics and pharmacodynamics modelling approaches, such as population pharmacokinetic, exposure-response, quantitative system pharmacology, and other model-based analyses.-Perform clinical trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 reference list for study.Study Planning:… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads ... and Regulatory Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally- Creates a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development, in addition to colleagues in QCP. QSP ... Scientists have the opportunity to work within the QSP Model Development Team (MDT), a formal cross-functional framework for collaborative development and application of QSP within Oncology/Immuno-Oncology. ResponsibilitiesDevelop and apply Quantitative… more
- Merck & Co. (North Wales, PA)
- …negotiating and maintaining critical external partnerships.--Evaluating pre-clinical and translational work for the purpose of generating early clinical ... development plan and Investigational New Drug applications;-Developing clinical development strategies for investigational or marketed Oncology drugs-Planning clinical trials (design, operational plans, settings) based on these clinical development… more
- Merck & Co. (Rahway, NJ)
- …publication.Specifically, the Director may be responsible for:-Evaluating pre-clinical and translational work for the purpose of generating early clinical ... development plan and Investigational New Drug applications;Developing of clinical development strategies for investigational or marketed Oncology drugs;Planning clinical trials (design, operational plans, settings) based on these clinical development… more
- Aequor (South San Francisco, CA)
- …motivated individual Scientist 1/3 to join the Department of Preclinical and Translational 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 models development to determine the PK and metabolic fate of our candidate therapeutics. The… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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 partner, provide oversight of business demand to balance R&D IT portfolio and to ensure that partners… more
- Merck & Co. (Rahway, NJ)
- …The Senior Director May Be Responsible For:Evaluating pre-clinical and translational work for the purpose of generating early clinical development ... plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or marketed Oncology drugsPlanning clinical trials (design, operational plans, settings) based on these clinical development strategiesMonitoring… more
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