- Merck & Co. (Rahway, NJ)
- 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
- Merck & Co. (Rahway, NJ)
- …including Global Project and Alliance Management, Product Development Team (PDT) Leaders, and Clinical Study Managers regarding study budgets, site and ... toolkit beyond standard P&L analytical approaches, including big data analysis, clinical studies , partnerships and collaborations management, and resource… more
- Insmed Incorporated (San Diego, CA)
- …including monitoring of clinical studies , review & interpretation of clinical trial data, authoring clinical study and regulatory communications and ... for all issues identified which may affect the quality and integrity of clinical studies .Medical monitoring, coding, and data cleaning in collaboration with … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to… more
- Merck & Co. (Rahway, NJ)
- …- The Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, ... safety and efficacy as well as new drug applications, clinical study reports, or publication; and Participating...of Clinical Scientists in the execution of clinical studies Work closely with a cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... studies : Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management...updates; Responsible for valid clinical interpretation of study results as Clinical Study … 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 ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and ... development of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs), for assigned… more
- Merck & Co. (North Wales, PA)
- … clinical data/medical protocol deviations in collaborations with the Clinical Director . Other responsibilities include: Collaborating cross-functionally in ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...the development of Protocol and related study materials (eg, ICF documents / amendments); Partners with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and externally Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data ... trials from protocol finalization through closeout. Relationships Reports to: Director , Clinical Operations. Essential Functions Collaborate with internal… more
- Merck & Co. (Rahway, NJ)
- …post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory ... reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and...safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in… more
- Genmab (Plainsboro, NJ)
- …RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead for both early and ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Clinical Scientists (CS)- Interpretation and presentation of clinical study (ies) data to internal and external stakeholders- Provides ... with the CDL- Contributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures (TLF)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external stakeholdersProvides ... collaboration with the CDLContributes from a medical strategy standpoint to developing the Clinical Study Report (CSR). May review tables, listings, and figures… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Novo Nordisk Inc. (Omaha, NE)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Affairs (FMA), this position has primary responsibility for directing clinical engagement efforts and developing/implementing medical account strategies on behalf… more
- Merck & Co. (Rahway, NJ)
- …real-world evidence data generation and coordinates local data generation studies with V&I Outcomes ResearchSupports the Investigator-Initiated Study ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director , Human Factors plays a pivotal role in combination product development (both design and process), commercialization and lifecycle ... in our company's portfolio and pipeline including acquisition products.This Director position will interact extensively with all subject-matter experts within… more
- Eisai, Inc (Jersey City, NJ)
- …is your profile, we want to hear from you. Job Summary The Associate Director , Medical Writing will be the designated Lead Medical Writer for multiple Programs, ... writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Merck & Co. (Rahway, NJ)
- …and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications ... Job Description Director -QP2-IO We are seeking an experienced talented...Director . QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development… more
Related Job Searches:
Associate Director Clinical Study,
Clinical,
Clinical Director,
Clinical Study,
Director,
Study,
Study Director