- 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
- Genmab (Plainsboro, NJ)
- …As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director , USMA Solid Tumor Portfolio. This role will report to the VP/Head ... solid tumor therapies and relevant studiesProvides US market input to Global clinical development and Global Medical Affairs programs, staying abreast of the… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for… more
- Genmab (Plainsboro, NJ)
- …our purpose.Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director , Global Drug Safety & Pharmacovigilance Physician serves as the safety ... in audit and inspection activities as relevant.Requirements MD required; clinical research and/or fellowship training in oncology/hematology, pharmacology or other… more
- Merck & Co. (San Diego, CA)
- …and biobanking. You will serve as a strategic partner to our discovery and clinical colleagues and will shape data science and AI/ML driven discovery strategies ... Job DescriptionThe Precision Genetics group within the Data and Genome Sciences Department is recruiting a...generate novel CDx models that can be deployed in clinical trials. You will also support preparation of regulatory… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Sr. Director of Technical Transfer is responsible for activities related to technology transfer from external and internal customers. This ... aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …inclusion in our clinical portfolio. Relationship This role reports into the Director of Clinical Research Equity supporting the strategy across NACD. This ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...to the needs of patients, sites, and caregivers With Director , serve as NACD SME on clinical … more
- Eisai, Inc (Nutley, NJ)
- …is driven to use cutting edge modeling approaches to advance the clinical and translational research in Neuroscience. This individual will provide scientific ... across all phases of drug development. The complexity and scale of data being generated has grown significantly and requires strong scientific contributions to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and execution of National Advisory Board meetings, at the discretion of Executive Director ) Deliver clinical data and other presentations at National ... for select clinical trials, in collaboration with Clinical Director and Clinical Operations...gain feedback from advisors Support other advisory boards with clinical data and other medical presentations Partner… more
