- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …stud(ies).Ensures trial master file is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the Study ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …are an equal opportunity employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analysesThe Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting- Develop DSI programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...(global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Insmed Incorporated (Bridgewater, NJ)
- …internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non- clinical safety , contract research organizations ... for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development, the role focuses on LC-MS/MS of small and large… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Pharmacology and Pharmacometrics (CPP) - 2406190600W **Description** Johnson & Johnson is recruiting for an ** Associate ... health for humanity. Learn more at https://www.jnj.com/ . The Therapeutic Area (TA) Clinical Pharmacology (CP) Associate Director role within Clinical… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Wednesday, May 8, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director...procedures and oversees the quality of the data and safety of the patients. Communicates deviations from the protocol,… more
- Bristol Myers Squibb (Trenton, NJ)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Associate Director Clinical Site Operations provides strategic oversight, ... and other applicable federal (FDA) and state regulations. The Associate Director Clinical Site Operations...ensure overall data quality, integrity, and patient protection and safety + Manages CRO relationship and oversight to ensure… more
- Merck (West Point, PA)
- …manufacturing of vaccine and biologic drug substances (DS) as the Executive Director for the Bioprocess Clinical Manufacturing & Technology (BCMT) organization, ... Advanced Biotechnologies (VAX) Process R&D in Development Sciences & Clinical Supply (DSCS) is responsible for the development and...GMP manufacturing. The individual will report directly to the Associate Vice President of VAX Process R&D and will… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... Value Proposition: Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director EOHSS Industrial Hygiene - New Brunswick** The primary ... is to support Bristol Myers Squibb (BMS) as the Associate Director of Industrial Hygiene for the...Brunswick Facility within the Department of Environmental, Occupational Health, Safety and Sustainability (EOHSS). This position reports to the… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Scientific Associate Director , DMPK Project Representative** Challenging. Meaningful. ... drug-interaction potential of drug candidates. Working closely with drug safety and clinical pharmacology, Dev DMPK plays...across the globe. PCO is looking for a Scientific Associate Director to join the Dev DMPK… more
- Bristol Myers Squibb (Trenton, NJ)
- …data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on managing ... support of BMS medicines and all phases of associated clinical trials. The RAD oversees their regional team to...timelines + Contributes to managing external communication when significant safety issues arise, with the well-being of patients being… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …professionally to achieve your own career goals. **Job** **Title:** Scientific Associate Director **Location:** New Brunswick **Division:** Global Production & ... at all microbiological testing locations in the BMS network. The Scientific Associate Director will also ensure appropriate strategies for DP-related… more
- Bristol Myers Squibb (Princeton, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results… more
- Bristol Myers Squibb (Princeton, NJ)
- …efforts. QSP modeling has become an important component of discovery and clinical development. QSP models are mechanistic, mathematical models, based on integration ... of non- clinical / clinical knowledge and data to represent varying...engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the… more
