- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... clinical/commercial manufacturing, process characterization and validation, and manufacturing CMC development strategy. Remote (only in corp. office for purposeful… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of ... the Technical Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Associate Director , Global Strategic Operations & Capacity Planning Head as part ... or related field. Minimum 8+ years of industrial biologics CMC development or manufacturing experience, CAR-T experience is highly desirable. Extensive experience… 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)
- …of established and new assay technologies such as NGS, IHC, PCR etc.Knowledge of drug development process and an understanding of how diagnostic development ... of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role...for the therapeutic, covering all areas from CDx assay development through CDx approval and launchLeads CDx Partner evaluation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.Participate in global product team meetings ( development ... implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director , Quantitative Systems Pharmacology (QSP) will work within the ... development and application.Align QSP model deliverables with the Model-Based Drug Development (MBDD) plansUtilize virtual population workflows and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and ... and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and other vendors to ensure high quality of coding deliverables to support drug development processes and global submissions. This position provides leadership ... ensures quality delivery of medical coding for clinical trials, clinical development , and regulatory submissions. Develops and proposes strategies for medical coding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... Pharmacometrics/ Quantitative Clinical Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical and … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in data science / business intelligence / statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO ... end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development ... of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drug Substance, Drug Product, or New Modality) process and product development preferred Travel Ability to travel up to 30%. Global and domestic travel ... rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality)...and associated teams for internal and external sites and development projects. Serve as the main interface to internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Experience Qualifications- At least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research, Pharmaceutical ... activities assigned, eg for a clinical study: provide input on the development of study protocol (design, sample size, statistical analysis strategy); Review CRF;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC ... plan.- Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of analyses and reporting of clinical trials preferred- Knowledge of all phases of drug development , including early and late phase clinical development and ... and quality. Responsibilities include: contribute to CRF and SDTM standard development , develop, implement, and maintain SDTM, ADaM dataset and TLF standard,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other government and local agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+ years of ... research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and formulating business relevant strategic recommendations Strong understanding of drug development , commercialization, and lifecycle management Works ... and recommendations through formal and informal channels Leadership and development : Capable of assuming role of Director ...and development : Capable of assuming role of Director MAPA Insights when needed, such as representation on… more
- Merck & Co. (Rahway, NJ)
- …in one of the above disciplines plus 5 years related experienceExperience with the development drug -device combination product or a medical device component of a ... Development (DD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and effective… more
- Merck & Co. (Rahway, NJ)
- …of the MACS EDFE Leader include the following:The EDFE Leader role at the Associate Director level will serve as a technical mentor and process team ... and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The Associate Director will serve as a team member of the MACS Center… more
