- Eisai, Inc (Nutley, NJ)
- …(feasibility, start-up, conduct and close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support , creates, and ... country specific documents and all other documents as requested by Clinical Operations Maintains sponsor team member staff assignment list for Eisai systems… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations ) Project Lead is primarily responsible for developing and updating Study Supply ... rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at...service providers and working with internal departments to progress clinical supply projects. Every effort has been made to… more
- Merck & Co. (Rahway, NJ)
- …a highly motivated individual to work in a fast-paced job that provides operations experience and a strong understanding of engineering fundamentals. The MACS ... Operations Specialist position will report to the Director, Engineering...molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey.… more
- Merck & Co. (Rahway, NJ)
- …(SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience our culture firsthand - one ... while developing and expanding your career.-- As GxP Strategic Lead , you will be part of a team that...methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... 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. (Bernards, NJ)
- …scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads ... primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within… more
- Merck & Co. (New York, NY)
- …and retention efforts to achieve study milestones.Upon request from Global Clinical Trial Operations (GCTO),Recommends study sites and identifies potential ... applicable policies.Maintains current knowledge and comprehension of dynamic scientific and clinical environment in the Company's Areas of Interest (AOI) for the… more
- Merck & Co. (Rahway, NJ)
- …experience partnering for Pharmaceutical development / CMC with Quality, Regulatory, Operations , Non- clinical , Clinical , and other functional areasExperience ... (SPD) team. The successful candidate will be expected to lead the team focused on the design of new...exposure to all stages and aspects of development (preclinical, clinical , and commercial) and cGMP industrial backgroundExperience in developing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …MSA discussions of External Vendors by engaging with key cross-functional stakeholders ( Clinical Operations , Clinical Biomarkers, QCP, etc.) for establishing ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution plans across and effective alignment within (eg with translational research, clinical operations , clinical development, medical affairs CSPV and ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of Phase I-III clinical studies. Partner with Project Management, Clinical Operations and other functional groups to ensure budgets are always ... maintained and accurate. Accountable to the Global Team Lead (GTL) and GPT (Global Project Team) for the...and control of functional budget in support of global operations of RD unit. Partner with global function leaders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management, ... Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …developing an Integrated Evidence Plan (IEP) for the assigned compound.Responsibilities- Co- lead a cross-functional Evidence Generation Team (EGT) for the assigned ... and as a subject matter expert (SME), in alignment with the GMAT Lead , develop an Integrated Evidence Plan (IEP), which includes an evidence gap assessment,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …As a senior member of Clinical Operations , the Senior Director, Clinical Operations will lead the full development team in designing, planning, ... operational processes and requirements, and effectively applies this knowledge to lead the clinical operations department to achieve corporate objectives. +… more
- AbbVie (Jersey City, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description AbbVie Clinical Data Strategy & Operations is the best-in-class team within ... acts as single point of contact and accountable operational lead from DSS. + Coordinates associated DSS study teams...in oversight of vendors and provides feedback related to clinical trial operations , issues, and trends in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations ) Project Lead is primarily responsible for developing and updating Study Supply ... and updates Study Supply Plans in close communication with CSO project Management Lead + Responsible for the Clinical Label Development process which includes… more
- AbbVie (Florham Park, NJ)
- …audits + Participates in oversight of vendors and provides feedback related to clinical trial operations , issues, and trends in performance + Responsible for ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with global line functions, assigned Clinical Scientist and Clinical Operations associates. + Supports Program Lead MD (and/or Sr. MD) and frequently ... clinical deliverables within the assigned section of a clinical program with minimal supervision from Program Lead... clinical program with minimal supervision from Program Lead MD. + Manages all operational aspects and drives… more
