- 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
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead, you will ... of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members… 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
- George Washington University (Washington, DC)
- … of Clinical Education faculty and the Field Work Coordinator, the Associate Director of Clinical Education Programs partners on program design, ... faculty leaders, manages the development, implementation and evaluation of the clinical education/field work experiences in the Department of Health, Human Function… more
- Merck & Co. (North Wales, PA)
- …the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your ... management, communication, and collaboration skills in support of our clinical trials. Job Responsibilities Responsible for the operational planning, feasibility,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… 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
- 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)
- …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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clearance, supply / device management) Responsible to ensure timely availability of clinical study materials and ancillary supplies to North America distribution ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… 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)
- …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
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...product labeling as it relates to the use of study results in US promotion.Maintain current awareness of evolving… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy Interacts frequently in ... scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making for the NASH franchise… more
