- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study Team Leader for the assigned ... and immune disorders.SummaryThe incumbent will be responsible for ensuring execution of clinical studies across geographic regions, in adherence to Good … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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 AROs/CROs.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic... trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction ... of the Senior Director , GMA Oncology (Global Medical Affairs team lead for...as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Responsible, with limited supervision, for study activities assigned, eg for a clinical study : provide input on the development of study protocol ... The position will act as main statistical contact for the assigned studies , in particular in cross-functional Study team(s).Responsibilities- Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant regulatory requirements. This position has experience working on Phase I-IV study studies within the medical device and/or pharmaceutical industry ... according to applicable Daiichi Sankyo and regulatory requirements.Functional Expertise:Reviews/approves clinical study related documents that are owned by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... or independently leads the design, preparation and analysis of epidemiologic studies , including real-word evidence (RWE), supporting senior management in various… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor selection criteria.- Problem solves and negotiates in most service types, studies , and programs- Responsible for the development and management of other ad ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM)) ... ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity.- Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop ... for the assigned oncology asset(s). This person will report to the Sr Director , Global Oncology Value Pricing & Access, and will be responsible for providing… more
- Insmed Incorporated (Bridgewater, NJ)
- …organizations etc.) to build and to execute the bioanalytical strategy specific to clinical development programs.Participate in clinical study design and ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies . This translational role resides… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HEOR is a significant contributor to the development ... and communication of HEOR evidence to demonstrate the value of Insmed's product(s). The Associate Director will work closely with HEOR team members and others… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...to drive the successful translation of preclinical findings into clinical applications. Your expertise will be critical in advancing… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... or indication product line. This role leads the protocol statistical section development, study setup, execution, analysis, and reporting of clinical trials, and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix ... clinical studies and programs. As an Associate Director a typical day may include...in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ... provide scientific expertise necessary to design and deliver on clinical studies and programs. May be responsible...programs. May be responsible to manage one or more clinical scientists. As an Associate Director… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Pharmacology and Pharmacometrics - 2306103445W **Description** Janssen Research & Development, LLC is recruiting for an ... Associate Director , Clinical Pharmacology and...clinical pharmacology strategy including design of Phase I clinical pharmacology studies and/or use of alternative… more
