- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science ... associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data… 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 ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable for the… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...Company 's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for ... as a member of the various cross-functional forums including, Publications Planning, Clinical and Safety sub-teams, Global Brand Team, and Global Product Team to… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics ... to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical education, research grants,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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 ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …stakeholders, the Director of S&PE will establish the North America Clinical Development (NACD) strategy for the development and execution of customized ... 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective;… more
- Merck & Co. (South San Francisco, CA)
- …the strategic plan within CMD, including integration of new technology platforms, pre- clinical models, human biology, data science, while focusing on uncovering ... Job DescriptionThe Executive Director of Cardiovascular (Cardio-renal disease & Heart Failure)...and complement internal pipelineMonitor emerging biology and basic & clinical research within cardio-renal diseases & hear failure, and… more
- Merck & Co. (Rahway, NJ)
- … Management, Global Clinical Data Standards Working closely with the Global Clinical Data Standards (GCDS) Sr. Director of Operations and Reference ... to and provide insights into implementation of strategic direction.In support of the Senior Director , Operations and Reference Data Management, ensures… more
- Merck & Co. (Rahway, NJ)
- …area capabilities. Partnering with key stakeholders, individual will benchmark competitor clinical data , business models and capabilities to develop insights ... innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for ... medical education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within… more
- Merck & Co. (Rahway, NJ)
- …strategic teams that include the Process R&D and Development Sciences and Clinical Supplies extended leadership team and Small Molecule Process R&D's Scientific ... managing budgets to align actions with strategy.Supervises 5 Directors or Senior Directors, and through them, approximately 85 scientists, people managers, chemical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …, Global Medical Affairs (GMA), Gyn Oncology, under the direction of the Senior Director , GMA Oncology (Global Medical Affairs team lead for compound), ... medical information, internal education, publications, scientific exchange and external data communication, and stakeholder scientific engagement. Responsible for managing… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Director of Immuno-Metabolism will be responsible for overseeing and facilitating the research in metabolic disorders & inflammation, in the ... CMD strategy, including integration of new technology platforms, human biology, and data science, with a focus on uncovering novel biology in immuno-metabolism to… more
- Merck & Co. (Rahway, NJ)
- …provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director ... production, utility systems and associated infrastructure.- Responsibilities of the Senior Specialist - Manufacturing Automation include the following:The automation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Compliance, Finance, HEOR, and Market Research. The position has high exposure to senior management and requires a highly motivated individual who is able to work ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... assessing competitive impact to the disease strategy and the strategic choices for clinical development and data generation- Develop and define DAST best… more
