- Daiichi Sankyo, Inc. (Bernards, NJ)
- Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , ... areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... early clinical safety for our Rare Disease/Specialty Medicine portfolio. SummaryThe Director , Clinical Safety, will be a product safety lead or part… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... as well as other research areas centered around rare diseases and immune disorders.SummaryThe Director , Clinical Safety, will be a product safety lead or part of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... 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. (Bernards, NJ)
- …function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate communication for the products. The position must effectively collaborate with Clinical Research and with co-promote or co- development partners to ... efforts needed in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of global forecasts of inline brands and assets / indications in clinical development .- Support commercial assessment of Early-Stage assets for assigned ... including Marketing, Supply Chain, Finance, Market Access, Medical Affairs and Clinical Development .- Partner with regional commercial analytics for performance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on operations concerning risk control and ... Statistical Monitoring during study conduct to detect oddities, trends in clinical variables, or site differentials, following the critical variables defined during… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to ... works under some supervision to solve complex study problems.Responsibilities- Protocol Development , Case Report Form (CRF; review), Statistical Analysis Plan (SAP),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research organization. Partner with the other members of the Daiichi Sankyo Business Development team to assist with Development stage opportunities in cancer ... documents for submission and presentation to management. Report to global business development leadership and cross-functional senior leadership on the status of key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU....may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.Ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …accountability for operational study level time, cost and quality deliverables.Lead the development of the clinical study plan including critical path activities ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and consistent application of external data vendor access standards across DS clinical programs. Participate in the development of and ensure compliance ... areas centered around rare diseases and immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member of the Biostatistics and Data… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (nitric oxide) Requisition JR000014860 Director , Clinical Development and Medical ... Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs plays a key role… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- ** Director , Clinical Development ** **Join a Legacy of Innovation 125 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of ... medical guidance for coding of AEs, medical history, and medications when needed ** Clinical Development Expertise Strategy:** + In collaboration with the Global … more
- Sanofi Group (Bridgewater, NJ)
- …progress to make a real impact on millions of patients around the world. The Director Clinical Development is the clinical /medical/scientific expert who ... **Global Clinical Development Strategy Expert - Vaccine** **Location: Waltham, MA** **Work model: Hybrid** **About the Job** We are an innovative global… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking an Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …direct reports. **Responsibilities:** **Operational Strategy:** + Align with the Head of Clinical Development Operations or Senior Director , Clinical ... centered around rare diseases and immune disorders. **Job Summary:** Senior clinical operational leader accountable for operational planning and execution of FIH,… more
