- 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)
- …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)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... into systems (disease) modelsContribute to the design, execution and interpretation of clinical and non- clinical studies .Partner with external groups to… 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)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies . Partner with Project Management, Clinical Operations and other ... global business partners to develop budgets and analytics for ongoing and new pipeline studies in support of the annual process of extracting the optimal value out… 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)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… 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
- 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Imaging...study 's imaging components and endpoints. + Serve as Study Director for clinical trials ... support the scientific imaging aspects and tumor response assessment of oncology clinical studies . We assume you will be a member of cross-functional program… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …direct impact. Join Gilead and help create possible, together. **Job Description** The Associate Director , Clinical Records & Information Management will ... partner with cross functional teams as well as Clinical Research Organization (CRO and Functional Service Provider (FSP)...& CTMS process and systems, pervious experience with operational study and site management and a demonstrated track record… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are looking for an Associate Director , within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing ... Ridge, NJ location.** **A day in the life an Associate Director may look like:** + Develop... clinical pharmacology subject matter expertise to the Clinical Study Team/ Development Team. + Participate… 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 ... opportunity employer including veterans and people with disabilities. **Summary** The Associate Director will be responsible for developing and implementing… more
