- Merck & Co. (Rahway, NJ)
- …support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint ... and supervise the activities of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional group of experts in… more
- Merck & Co. (Rahway, NJ)
- …Late Stage Analytical Program LeadAbout the roleYou will join our Large Molecule Analytical Validation team to serve as an Analytical Program- Lead . The lead ... development to commercialization as part of the Development and Commercialization Team . The incumbent should apply stage appropriate scientific rigor, ensure… more
- Merck & Co. (Rahway, NJ)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... assigned to a development project as neededLead biostatistics in early or late clinical development planning to ensure that study designs are consistent with… more
- Merck & Co. (Rahway, NJ)
- …analysis plans and reports related to COAsWork closely with the cross-functional study team to interpret results from COA endpointsCollaborate on quantitative ... the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead , the Principal Scientist has responsibility for supporting or co-leading global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …developing the Global Clinical Science Strategy and delivery of clinical studies in late stage development. Lead and manage the multiple late development ... (Oncology) Clinical Science resources are deployed to clinical studies from end to end in...end in collaboration with GCLs, Physician Scientists and the study team (data management, clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... updates; Responsible for valid clinical interpretation of study results as Clinical Study ...KOLs or major institution, eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . Responsibilities: Study Strategy: Clinical study ... updates; Responsible for valid clinical interpretation of study results as Clinical Study ...KOLs or major institution, eg NCI.Scientific, Program related: Integrated Study Team (IST) representative: Creates early development… more
- Merck & Co. (Rahway, NJ)
- …interfacing with scientists who are manufacturing drug substance to support early clinical studies , scaling up new chemistries, and exploring new technologies. ... Engineering and will be a member of the EF Team at the Rahway NJ facility. This position will...members to ensure the quality and safe delivery of clinical supplies, and ultimately to enable flexibility and speed… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … clinical activities as appropriate.Responsibilities Clinical Operations Study / Program ManagementCompany Sponsored Studies (CSS) Support the preparation, ... clinical operations systems for management of company sponsored studies review and approvals are current and accurate.Liaison and...key activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... all aspects of clinical pharmacology and biopharmaceutics studies ; clinical pharmacology project lead ;...interactions at project level, interacts with regional and global study and project team members, and to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …representative on Clinical studies or take a lead on Clinical pharmacology studiesServe as QCP sub- team leader and represent the QCP function at ... Summary This position will be part of the Quantitative Clinical Pharmacology (QCP) team and support drug... Clinical Pharmacology will support or take the lead on generation of study designs, protocols,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other activities including but not limited to cross-functional team meetings, project team meetings and observational study protocol reviews. One of the key ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and execution of observational research / Real World Evidence studies to support the Evidence and Insights Generation Plans… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy: Develop and implement ESR team operational strategies for externally sponsored studies . Serve as the global ESR lead for assigned assets to ensure ... ESR and Medical teams as well as alliance partners, promoting a cohesive team approach.Regulatory and Safety Compliance: Understand study conduct from supply… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including, Publications Planning, Clinical and Safety sub-teams, US and Global Brand Team , and US Product Team to inform clinical development, ... USOMA plan including Launch Readiness and Life Cycle Management. Leads the team for this compound.Responsibilities- Responsible for the development of the USOMA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …assigned studies in close collaboration with the QCP, Clinical Biomarker Team , Companion Diagnostics, the Clinical Study Teams, Central & Specialty ... cross-functional internal and external stakeholders including but not limited to QCP, Clinical Biomarker, Companion Diagnostics, Clinical Study Teams,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex… more
