- Merck & Co. (Rahway, NJ)
- …Rahway is looking for an Associate Director - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable ... is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict...for externally sponsored studies. Serve as the global ESR lead for assigned assets to ensure optimal execution and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory ... Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk...Responsible for Strategic Application product roadmaps to meet business objectives. Lead the definition of solutions based on business needs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for medium complexity ... strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex biostatistical initiatives, with some level of supervision,… more
- Merck & Co. (Rahway, NJ)
- …manufacturing to manage clinical development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research… more
- Merck & Co. (Rahway, NJ)
- …and increased integration of Chemistry Manufacturing & Controls (CMC) and Clinical strategies.- Position Description/Summary: The Associate Director, Project ... development plans.Under the guidance of the Director & Portfolio Lead , the core responsibility of this individual will be...programs in harmony with the portfolio. In addition, the Associate Director will be expected to participate in development… more
- Merck & Co. (Rahway, NJ)
- …Business Development opportunities. Leverage scientific acumen to partner with discovery and clinical colleagues in shaping research programs. Lead team analysis ... Job DescriptionPosition Description: Associate Director - Immunology Competitive Intelligence Immunology Competitive Intelligence Associate DirectorUnder the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's ... principles and risk management techniques to positively support and influence clinical and commercial combination product development and launches to ensure they… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …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. ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the quality and timeline of vendor workCollaborate with study medical lead and biostat to ensure availability of necessary dataCoordinate author review/approval ... company, including authors, researchers, investigators, GMA medical leads, R&D clinical leads, bio stats and Publications Committee members on publication… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Eisai, Inc (Nutley, NJ)
- …evidence (RWE) development programs in support of global market access initiatives. Lead clinical meaningfulness initiatives that address issues such as payer ... a pharmaceutical company in Nutley, NJ. Assess real-world data gaps and lead evidence generation process for the collection and dissemination of information, data,… more
- Merck & Co. (Rahway, NJ)
- …activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead .Develops worldwide product regulatory ... all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for… more
- Merck & Co. (Rahway, NJ)
- …with a growth mindset.Position Description: The Senior Director, Global Regulatory Lead , is responsible for development and implementation of worldwide regulatory ... all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for… more
- Merck & Co. (Rahway, NJ)
- …SM PR&D pipeline. Responsibilities: Under the scientific direction of a facility lead , the Operations Specialist will participate in equipment setups, raw material ... aiding technology development, and supplying Active Pharmaceutical Ingredient (API) for clinical use and drug product development. This will involve handling of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be ... a team-based environment, on an assigned production shift schedule.Key Responsibilities Lead and supervise multiple units within the CAR-T process operations (ie… more
