- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ location for a Senior Director , Clinical Operations.The Senior Director , Clinical Operations ... Clinical Trial Manager(CTM), as neededRequirementsSpecial knowledge or skills needed and/or licenses or certificates required Bachelors degree in (para)medical,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head has ... management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …program in a specific indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; ... Represents clinical function at meetings with health authorities; Oversees management...of CRO. Occasional interactions with CRO senior leadership as needed ; Participates in creation of developmental and regulatory strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... access Provide medical and scientific input to Marketing/Market Access departments as needed Project management liaison: Assist in developing clinical program… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working ... with the team to execute the global clinical development plans of brensocatib for the HSindication. Tasks...study design that arise during study.Provide medical expertise where needed .Collaborate with team and CROs to prepare and finalize… more
- Merck & Co. (North Wales, PA)
- …the Datavision publications database and generate reports for stakeholders as needed .Build and maintain excellent relationships with clinical investigators, ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source...experience at or supporting -pharmaceutical/biotech companies related to the clinical development processAt least 2 years of experience in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evaluations Support external advisory engagements through peer-to-peer interactions, as needed Stay abreast of evolving regulatory requirements, clinical ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...evidence-based M&A advisory services. Reporting into the Senior Medical Director , M&A Scientific Advisory, the Medical Director ,… more
- Eisai, Inc (Nutley, NJ)
- …understanding of statistical methodologies and their application in the context of non- clinical studies and related projects in AD and other therapeutic areas as ... needed .Overall, the incumbent is entrusted with the leadership and...deliverables and timelines within GV&A projects related to both clinical trial setting and observational studies.Serve as the lead… more
- Novo Nordisk Inc. (Chicago, IL)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to...the SD serves as a key member of the Clinical Trial Strategy Team, provides additional analytic support to… more
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large ... bioanalytical methods and sample analyses of regulated bioanalytical assays for clinical , nonclinical and biomarkers studies. This translational role resides within… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director , Global Oncology Medical Affairs is responsible for developing the Global ... 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)
- …describe complex disease processes to understand and evaluate the implications of clinical trials and real-world data; demonstrate the value of interventions beyond ... reviews, comparative effectiveness assessments, and indirect treatment comparisons as needed to identify evidence gaps, opportunities for strategic evidence… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... and Australian agencies and other international and/or local health authorities.The Director of Quality is responsible for providing leadership and Quality… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …statistical programming of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as ... with other functional areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs, etc. Qualifications: Successful candidates… more
- Lundbeck (Chicago, IL)
- …US medical insights for assessment of global Lundbeck BD opportunities and pipeline clinical development. Furthermore, the Sr Med Dir will build the US MA's future ... US cross-functional teams, especially Digital & Data Analytics function, to accelerate needed infrastructure within US Medical Affairs. We seek a senior, strategic… more
- Eisai, Inc (Exton, PA)
- …through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on the success ... and within budget, as well as identify major milestones and critical steps needed to the success of their projects and the development programs they support.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Executive Management and Board of Directors. Relationships Reports to the Sr Director Omnichannel Engagement. Responsible for the management of a media team that ... revenue and competitive impact Implements pre-marketing strategies and develops clinical thought-leader relationships and involvement Leads in the development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …a smooth transition of projects, recommends, and implements new technologies, as needed and supports Supply Chain Management with technical issues post first ... manufacturing, technology transfer, site-to-site technology transfers and PPQ as needed . Conduct data review and analysis, data-driven decision-making process, and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Executive Director (ED) will provide leadership to the DSPV Medical Safety Team. ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre- clinical groups, Regulatory CM&C and other appropriate group within ... the company as needed .ResponsibilitiesManages, directs, and drives the strategy for all Regulatory...Company. Also communicates with outside consultants (ie CRO's) as needed . Qualifications: Successful candidates will be able to meet… more
