- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …deliverablesWorks collaboratively with clinical project managers, statistical programmers, clinical research associates, and others to meet project ... Job Title:Head of Clinical Data ManagementJob Grade:G6/G7Department:Biostatistics and Data ManagementFLSA Classification: Manager's Job Title:Head of BDMDepartment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …complying with Novo Nordisk policies and procedures. Relationships This position reports to a Senior Director within the Clinical Data Science & Evidence ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Vice President, Medical & Science. Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research , Medical Writing, Program ... and international regulatory requirements Work with the VP Medical/Scientific Development, Clinical Operations, Non- Clinical Research , Medical Writing,… 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 ... (KOLs), Healthcare Professionals (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …other members of the Medical Writing team. Relationships The Director Medical Writing ( Director ) reports to a Senior Director of Medical Writing. A key ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are... clinical development and regulatory requirements of a clinical program. The Director will provide high… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... to maximize your potential with us? The Position The Director , CMR Insights Lead is responsible for leading the...eight (8) years of relevant experience required Experience in Clinical , Medical, Regulatory or Research and Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... manage cross-functional study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met according to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Serves as a primary source of medical accountability and oversight for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... project team members, and to a limited extent with senior management, and outside vendors; works independently for all...in Pharmacology or Pharmaceutical Sciences or PharmD with a clinical pharmacology research fellowship and 4 years… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryOversees a number of ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... skills, with mastery of English grammar and punctuation Demonstrated understanding of clinical research principles and the drug/device development process Keen… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … research vendors, & budget management. Relationships The Fellow reports to a Senior Director RWE and works closely with all colleagues in both the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...is responsible for supporting planning and execution of observational research / Real World Evidence studies to support the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's global ... a first, preliminary benefit/risk assessment and make available to senior leadership at DP0. Surface expert knowledge on safety...safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …high-level execution plans across and effective alignment within (eg with translational research , clinical operations, clinical development, medical affairs ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary A cross-Oncology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position supports ... safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.SummaryThis position is ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director...execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Director Global Medical Affairs Oncology (GMA), under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), is ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and… more
