- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a ... single or multiple clinical trials from strategy outline through to CSR by...implement, and maintain detailed, integrated trial timelines from the study outline through CSRDevelop initial recruitment projections and strategyApprove… more
- Genmab (Plainsboro, NJ)
- …and/or as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert...Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… 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 AROs/CROs.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead...and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical , medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing...through understanding and tactics to develop, execute and deliver clinical studies /programs on time with a focus… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... studies including study design, protocol development, CRF review, SAP development, analysis...review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study ... protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities;… 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
- Merck & Co. (Rahway, NJ)
- …of entire Clinical Teams in the execution of clinical studies .--Will report and work collaboratively with the- Associate Vice President to promote ... Job DescriptionOur Clinical Development teams manage studies to...safety and efficacy as well as new drug applications, clinical study reports, or publications.Participation in internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise: Study ... coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to ensure...DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure… more
- Merck & Co. (Rahway, NJ)
- …build and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...real-world evidence data generation and coordinates local data generation studies with V&I Outcomes ResearchSupports the Investigator-Initiated Study… more
- Pfizer (New York, NY)
- The Associate Director , Clinical Diagnostics will support development of Diagnostics and Global Diagnostic Strategies across therapeutic areas. We are ... flow cytometry + An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies , and the… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, ... PV Activities globally, including set up and conduct of clinical studies from a PV perspective. You...the Pharmacovigilance Operations team, you will report to the Director , PV Clinical Operations and will be… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Bristol Myers Squibb (Princeton, NJ)
- …and at governance meetings based on proficiency + **Provide input** to Phase 2/3 clinical study design and registrational strategy + **Accountable for the** ... Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis,...in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress. + Manages all aspects of Quality ... quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable...with senior level management, external vendors, collaboration partners and clinical study personnel for clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops 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:… more
- Bristol Myers Squibb (Princeton, NJ)
- …and success of the BMS R&D pipeline. This role reports to the Director , Clinical Data Management or Associate Director , Clinical Data Management ... is responsible for: **Project Management and Leadership** + Provides clinical data management leadership within the study ...Provides clinical data management leadership within the study team to align on and drive data collection… more
