- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full our ... Research & Development Division portfolio of clinical trial s .- GCS is accountable for the...business risks, & influence portfolio decisions with facts and data Demonstrates ability to balance strategy with ability for… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.Overview The Global Clinical Trial Manager, Team Manager (GCTM-TM) is responsible for line management of ... approximately 12 direct reports, including Clinical Trial Managers (CTMs) and Clinical Trial...execution, including setup of new protocol amendments, ad hoc data cuts, or temporary coverage.Provide strategic support for Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryReporting to the Senior Director , I&A, the Associate Director , Global Oncology Forecasting ... will drive creation of demand and revenue forecasts. The Associate Director is a dynamic member of...Integrate with the Global Marketing teams and provide a data driven point of view for inline and pipeline… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing the ... KOL's and meetings, Scientific Expert Committee meetings Communication: Transforms the clinical trial data into scientific and commercial communication Manages… 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. (Rahway, NJ)
- …of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... molecules, biologics, and vaccinesBroad understanding of drug discovery, development and research, clinical data coding and experience working within a regulated… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The Role The Associate Director of US Medical Affairs Hematology Strategy will report to the ... Director , US Medical Affairs Hematology Strategy Lead. S/he will...of clinical trials in hematology. Proficiency in clinical data review and interpretation.Experience in translating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads...all applicable regulations and guidelines and with Company Core Data Sheets and manages deviations. This position interacts across… more
- Merck & Co. (Rahway, NJ)
- …Description - - Our Company Research Labs IT team partners with the Clinical Trial Operations teams within the Research & Development division to create, develop, ... - Work closely with software engineers , UX designers, data engineers, quality engineers and other product teams and...product teams and product leadership - Ability to analyze data to make informed decisions, understand KPIs, user metrics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .-...with data manager to ensure high quality data .- Drug Development Strategy: Provides input to multiple aspects… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …work assignment and oversight of the group. This position reports to the Associate Director Data Management Operations. Business administration activities ... centered around rare diseases and immune disorders. Job Summary: The Manager, Clinical Data Repository Administration is a member of the Biostatistics and … more
- Merck & Co. (Rahway, NJ)
- …across technical transfer initiatives, working collaboratively with the Senior Director , Directors, and Associate Directors, and cross-functional teams.Utilize ... across inline program support projects, working collaboratively with the Senior Director , Directors, Associate Directors, and cross-functional teams.- Ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Merck & Co. (Rahway, NJ)
- …areas and routes of administration, including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of ... and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products.Principal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationships include colleagues from Medical Affairs, MA Omnichannel Engagement, Scientific Communications, Clinical Data Science & Evidence, Legal, NNI IT and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...you ready to make a difference? The Position The Associate Manager, under the Director of SP&I,… more
- Merck & Co. (Rahway, NJ)
- …trials and will interact externally with key opinion leaders.-Specifically, the Executive Director , PDT lead may be responsible for:-Evaluating pre- clinical and ... of external opportunities.-Provide support for other therapeutic areas regarding clinical issues related to oncology compounds.-The Executive Director /PDT… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Assistance & Affordability. Key internal relationships include brand… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data ... (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with senior level… more
