- Novo Nordisk Inc. (Plainsboro, NJ)
- …knowledge of applicable US and EU regulatory requirements and of the drug development process Experience in building and maintaining effective relationships ... Vice President, Medical & Science. Work with the VP Medical/Scientific Development , Clinical Operations, Non-Clinical Research, Medical Writing, Program … more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director US Oncology Policy position is a high exposure and high impact commercial role accountable for executing key policy initiatives ... ensuring appropriate patient access to our Company's life-saving cancer treatments.The Associate Director , US Oncology Policy will report to the Director of… more
- Insmed Incorporated (Bridgewater, NJ)
- …record of successfully leading toxicology programs through various stages of drug development . Experience in toxicology on biologics, oligonucleotides, and/or ... collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development , CMC, and program management to drive the overall… more
- Merck & Co. (Rahway, NJ)
- …Documentation Practices (GDPs), and S&E regulations as it pertains to pharmaceutical development . Experience with small molecule drug substance and/or biologics ... Good Manufacturing Practices (GMP) facility within the Process Research and Development (PR&D) organization which enables gain of critical internal experience during… more
- Merck & Co. (Rahway, NJ)
- …FDA; prepare our company's teams for meetings with FDA at any phase of drug development . Lead cross-functional efforts to prepare for advisory committees and may ... in biological science or related disciplineB.S., with minimum of 7 years of relevant drug development experienceM.S. with minimum of 7 years relevant drug … more
- Insmed Incorporated (Bridgewater, NJ)
- …PK, PK/PD and pharmacometric analyses for clinical and non-clinical studiesApply model-based drug development strategy to support clinical dose and dosing ... PKPD principles, ADME concepts, and clinical pharmacologyThorough understanding of overall drug development programs and familiar with clinical pharmacology… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic ... partnered with a more senior project manager in support of a larger, more complex drug development project. As a project manager this position is accountable for… more
- Eisai, Inc (Nutley, NJ)
- …and corporate objectives. Advanced understanding of clinical research and the clinical drug development process Advanced understanding of the Neurology or ... Oncology therapeutic areas Advanced understanding of the drug development plans, preclinical toxicology, toxicology, CMC, regulatory and other development … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Insmed Incorporated (Bridgewater, NJ)
- …of activities associated with delivering on Insmed's assets through completion of the drug development and launch processes. This position will be accountable ... required for the successful and timely completion of cross-functional plans. The Sr. Director of Program Management will utilize best-in-class program … more
- Merck & Co. (Rahway, NJ)
- …of trials, clinical trial design and Go/No Go decisionsFraming critical drug development questions for optimizing model-informed development -Responsible ... responsibility and independence in a similar role in pharmaceutical drug development or academia.-Educational background in pharmacometrics, biopharmaceutics,… more
- Merck & Co. (Rahway, NJ)
- …increasing responsibility and independence in a similar role in pharmaceutical drug development or academia. Educational background in pharmaceutical sciences, ... how (MIDD can drive portfolio and regulatory decisions Deep knowledge of drug development , pharmacokinetics and pharmacology and basic science skills required.… more
- Merck & Co. (Rahway, NJ)
- …research conducted in our state-of-the-art facility drives all aspects of drug discovery, development , manufacture, and commercialization of small molecules, ... our Rahway, New Jersey are focused on the discovery and development of world-changing therapeutics. Co-located with the corporate headquarters, our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization ... of relevant DSI stakeholders on the disease area, competitive landscape, and compound/ drug . May serve as speaker for program / franchise medical/scientific… more
- 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
- Insmed Incorporated (Bridgewater, NJ)
- …7+ years of experience in global regulatory labeling Full understanding of the drug development process Knowledge of global labeling regulations and guidances ... providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy for Insmed… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …seeking an Associate Director Immuno-Oncology as part of the Research and Development team based in Piscataway, NJ. Role Overview Legend Biotechnology is at the ... therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy... to lead our in vivo CAR-T cell therapy program . If you're passionate about advancing groundbreaking treatments and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …required- 15+ years industry or related experience required- Extensive early/late stage drug development experience ideally including time in role such as ... required- Proven global line management expertise; experience of performance management and development of Director + level staff required- Proven experience in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred- Demonstrated success in planning and executing strategies for global drug development , commercialization, and life cycle management preferred- Strong ... plus emerging pipeline assets to advance our research and development . This role will lead workstreams with highly matrixed...work to support critical strategic choices for the clinical program . The DAST Director will collaborate with… more
