- Eisai, Inc (Nutley, NJ)
- …start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates ... is your profile, we want to hear from you.The Clinical Trial Assistant will support all phases...consistency of clinical study and processes across clinical trials . Oversees and resolves operational aspects… more
- Eisai, Inc (Nutley, NJ)
- …a team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role...senior leadership role responsible for overseeing all aspects of clinical trial execution within a pharmaceutical or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical Operations...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Eisai, Inc (Nutley, NJ)
- …and external stakeholders and be the Lead Quality Assurance representative to clinical teams on assigned trials . This is a high visibility position with ... position is responsible for ensuring high quality execution of clinical trials from first in human through... Investigator Site Audits, Vendor Audits, GCP Document Audits ( Clinical Study Reports and Trial Master Files),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations , Regulatory Affairs CMC, and Clinical ... (SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).ResponsibilitiesLead the authoring, revising, and managing… more
- Genmab (NJ)
- …(eg competitive landscape) that represent operational risks for the execution of clinical trials within the given indication/program.Key contributor to the ... to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by... clinical drug development, with particular emphasis on clinical trial design, trial execution,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams.Responsibilities: ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Merck & Co. (Rahway, NJ)
- …clinical supply chain across the full company Research Laboratories portfolio of clinical trials .- GCS is accountable for the planning, sourcing, labeling, ... internal and external to GCS and serves as the lead GCS spokesperson at clinical and development... supply planning and incorporate them into the team's operations . - Focus on Customers & Patients. - Make… more
- Eisai, Inc (Lubbock, TX)
- …3 years MSL experience in Oncology/Hematology.Strong broad-based scientific and pharmaceutical knowledge. Clinical trial development and drug launch experience is ... and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr.… more
- Eisai, Inc (Exton, PA)
- …the operation of equipment to support preclinical and phase I to III clinical trials . Supervise change-over activities. Be responsible for ensuring routine suite ... your profile, we want to hear from you.The Associate Director of Biologics Operations Upstream and Downstream is responsible for leading and building a scientific… more
- Merck & Co. (South San Francisco, CA)
- …exposure-response models, quantitative system pharmacology (QSP) and disease progression models, clinical trial simulations, comparator modeling) that seek to ... for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is...improve cycle time, cost/size and number of trials , implementation of tools and framework for driving Go/No… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …non- clinical and clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for the ... execution plans across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and… more
- Eisai, Inc (Philadelphia, PA)
- …or clinical setting. Strong broad-based scientific and pharmaceutical knowledge Clinical trial development and drug launch experience is strongly preferred ... and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit...congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx ... scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations , Pharmacovigilance, handling and processing of raw data and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …systems including data management, statistical programming, digital technologies, and clinical operations .Design and implement a fit-for-purpose organization ... PV QA) and is a member of the leadership team. Lead an enterprise cross-functional QA team to deliver state-of-the-art...development in the pharmaceutical industry with involvement in regulated clinical trial and / or technical QA… more
- Eisai, Inc (Modesto, CA)
- …and/or clinical pharmacy and a basic understanding of commercial operations , including marketing and sales strategies. Proven performance in earlier role. ... information about Eisai, the company and it's hhc mission, and key scientific/ clinical information about Eisai's products, demonstrating a pattern of good judgment,… more
- Merck & Co. (Rahway, NJ)
- …development opportunities.Provide privacy support for the research organization, including global clinical trial operations .Partner with the Chief Privacy ... and external stakeholder engagement, working in close partnership with the operations lead .Specific responsibilities include:Oversee the team of Regional Privacy… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials . Recognizing that this development bottleneck may ultimately limit the number ... processes, and capabilities to accelerate all aspects of drug development and clinical trials . Formation Bio partners, acquires, or in-licenses drugs from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …disciplines and cultures.. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position ... management, and risk managementResponsibilities: Leadership, Direction, and Strategy:In collaboration with Clinical Development and Clinical Operations as… more
