- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , ... research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Daiichi Sankyo, Inc. (Bernards, 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. (Bernards, NJ)
- …vision including elements to achieve a Quality by Design (QbD) and Risk-Based Quality Management (RBQM) approach to clinical trial conduct. Major focus is on ... 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)
- …to management. Report to global business development leadership and cross-functional senior leadership on the status of key opportunities and seek approval ... teams in evaluating target opportunities partnering opportunities and producing high quality assessments of scientific and therapeutic hypotheses, as well as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …changing lives for a living. Are you ready to make a difference? The Position Senior , Clinical Informatics leads the functions in the Clinical Data Science ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leadership team and oversees NNI due diligence and other senior level oversight associated with the role Internal/external relationships:… more
- Merck & Co. (Rahway, NJ)
- …organizations ( as a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate ... effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Merck & Co. (Rahway, NJ)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a ... QP2 efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of… more
- Merck & Co. (Rahway, NJ)
- …DescriptionSr. Principal Scientist - Device Technical and Engineering Lead (Sr. Director Equivalent)Our company's Device Product & Process Development Team designs, ... tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with… more
- Genmab (Plainsboro, NJ)
- …is essential to fulfilling our purpose.The Role & DepartmentGenmab is seeking an experienced Senior Clinical Drug Supply Manager to join our Global Clinical ... a pivotal role in ensuring the timely delivery of high- quality clinical trial supplies for both early...can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...make a difference? The Position The Associate Global Medical Director will serve as a pivotal leader in advancing… more
- Merck & Co. (Rahway, NJ)
- …and platforms to benefit partners across Discovery Chemistry, Process Development, and Pre- Clinical Development.The Director reports to the Executive Director ... Analytical Enabling Capabilities Department has an exciting opportunity for a Director of Nuclear Magnetic Resonance (NMR).- The NMR Lead provides strategic… more
- Genmab (Plainsboro, NJ)
- …of the Global Medical Affairs department, this individual will report to the Senior Director of Medical Communications and Publications.We have a hybrid model, ... to be our best, and authentic is essential to fulfilling our purpose.The Director , Medical Communication and Publications will be an essential leader and responsible… 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 ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....Nordisk Inc. has a presence to ensure scientific accuracy, clinical appropriateness and validity of promotional materials from a… more
- Merck & Co. (Rahway, NJ)
- …and to external stakeholders.Identify patient-reported outcomes instruments for inclusion in clinical trials and disseminate health-related quality of life ... company's innovations and improve patient health outcomes. Under the guidance of a senior leader, this individual will support one or more V&I, Outcomes Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …discussions at meetings and conferences Communication: Works with the Global Medical Director (s) to transform the clinical trial data into scientific and ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Merck & Co. (Rahway, NJ)
- …areas regarding clinical issues related to oncology compounds.-The Executive Director , PDT Lead may:-Manage Directors and/or Senior Directors responsible for ... and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous… more
- Genmab (Plainsboro, NJ)
- …position is hybrid based in Princeton NJ (US) and will report to the Senior Director Global Access and Pricing. ResponsibilitiesLead the development of Global ... be our best, and authentic is essential to fulfilling our purpose.The RoleThe Director Global Market Access & Pricing Hematology will be responsible for developing… more
