- Daiichi Sankyo, Inc. (Bernards, NJ)
- …reviews performance and provides feedback on a regular basis.Assist or Lead training SOPs, GCPs, operational systems, etc.Qualifications: Successful candidates ... Leadership:Has primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …data collection and analysis. Opportunities are also available to become involved in and/or lead research papers and publications. The majority of time will be ... well as knowledge of the principles, methods, and procedures of basic medical and/or clinical research . Must have the ability to understand and follow basic… more
- Merck & Co. (North Wales, PA)
- …have excellent interpersonal and communication skills preferably practiced in an international clinical research environment. Leadership: The Sr. GTOS must be ... less experienced GTOS by demonstrating, on-the-job, the evidence based approach to clinical trial planning. Provides training , mentorship and instructions on GTO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... Visit) Training : compound, Diagnosis (Dx) Overview, in collaboration with Clinical Scientists (CS)Interpretation and presentation of clinical study(ies) data… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the ... clinical development in pharmaceutical/biotech industry, across multiple phases of clinical research (Phase 1-3)Knowledge of ICH-GCP and FDA regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Oversees typically ... 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)
- …to support efficient operations.Forecast demand, manage inventory, and prevent stockouts. Lead cross-functional collaborations, including Clinical Project Supply ... to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global Clinical Drug Supply… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …colleagues in both the RWE and the broader CDSE department. Essential Functions Lead observational research projects and manage vendors, contracts and budget. ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...is responsible for supporting planning and execution of observational research / Real World Evidence studies to support the… more
- Merck & Co. (PA)
- …scientific background and leadership skills to join our team as the Regional Cardiovascular Lead Manager for the East District. In this role, you will lead ... including overnight travel, and for meetings at HQ.The Regional Cardiovascular Lead Manager will report to the Director of Regional Cardiovascular Team.-Primary… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … evidence, and an in-depth understanding of the competitive landscape, market research , historical products, and payer landscape Lead market development and ... Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies… more
- Merck & Co. (North Wales, PA)
- …organizationKnowledge of US healthcare system, national and society treatment guidelines, clinical research processes, FDA regulations, and OIG guidelinesStrong ... Alignment Director to ensure consistent standards, processes, and harmonization for training activities (eg, clinical immersions, verbalizations, journal clubs,… more
- Merck & Co. (Lower Gwynedd, PA)
- …of QbD/DOE principles as well as data analysis and statistics for reporting clinical dataAbility to lead , mentor, and inspire scientists at various levels; ... Regulated Bioanalytics Department is seeking a Senior Director to lead the Regulated Robotics & LIMS team within the...including work at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and ... and clinical experience for all CSPV staff through continuous training and coaching. Building the talent pipeline, attracting, retaining, and developing talents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … training material as stated in the CSOPSupport and/or lead mitigation of CRO/vendor oversight findings. Additional Collaboration Opportunities:Support strategic ... primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The… more
- Merck & Co. (North Wales, PA)
- …R esearch & D evelopment Division at our Company (known as our Company Research Laboratories). The Project Managers in GPAM are core members of development teams at ... Under the guidance of the CIPM Director & Portfolio Lead , the core responsibility of this individual will...holistic portfolio management and increased integration of CMC and Clinical strategies . - Position Description/Summary: - The CIPM… more
- Merck & Co. (Rahway, NJ)
- … supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless ... Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal… more
- Merck & Co. (Lower Gwynedd, PA)
- …and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) Vaccines bioanalytical ... group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative… more
- Merck & Co. (Rahway, NJ)
- … supplies manufacturing, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development, and seamless ... Plant is a Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal… more
- Merck & Co. (Rahway, NJ)
- …(m/f/d)The Biotech facility embeds the latest technologies into the early stage clinical pipeline, helping to refine these technologies for inclusion into the ... Biotech provides Biologics Drug Substance manufacturing for Early Phase Clinical Supply and Technology Innovation implementation into the pipeline.The Assoc.… more
- Aequor (Thousand Oaks, CA)
- …EU Medical Device Directive, EN 60601and IEC/EN 62304) Experience supporting pre- clinical , clinical research , and/or pharmacovigilance activities Ability ... general supervision, provide tactical support activities to Quality Management System Lead . Specific responsibilities include but are not limited to: Manage the… more
