- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director, Financial Planning & Analysis, Drug Supply (GCS)Our Company's mission is to be the world's premier research-intensive ... company.- Our Company Research Laboratories ( drive break-through science through drug discovery, development and clinical evaluation to address significant unmet… more
- Merck & Co. (North Wales, PA)
- …interpretation.- Effectively communicate the study plan, update and output across different function areas to for optimal impact on projects. Contribute to Health ... to ensure implementation.- -Analysis, interpretation & impact: collaborate with line function experts to build formal analysis plans, participate in data analysis… more
- Merck & Co. (Rahway, NJ)
- …company is seeking leadership of our Biologics and Mixed Modalities Drug Product Development teams, responsible for the scientific and technical oversight ... of our small molecule, large molecule, and mixed modalities drug product formulation design, process development, and innovation to...have not been vaccinated against COVID-19 and an essential function of your job is to call on external… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently ... with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …design and leadership of clinical development plans, and addressing all regulatory, drug and patient safety, data, CMC, IP, patient selection, market acesss and ... acumen.Providing best practices to DS's overall development strategy and drug development goals. Influencing their adoption and facilitating cross-functional… more
- Merck & Co. (Rahway, NJ)
- …part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology ... registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the...have not been vaccinated against COVID-19 and an essential function of your job is to call on external… more
- Merck & Co. (Rahway, NJ)
- …team enables the translation of preclinical candidates into non-oral drug products.Primary ResponsibilitiesDesigning and developing sterile products for biologics, ... stage development candidates will include screening and developing robust drug product composition, developing scalable process and defining primary… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …quality oversight and strategic quality advice to the CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety ... stemming from audit outcome to increase compliance within CSPV function . Improve QA engagement with CSPV at the global,...agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+… more
- Merck & Co. (Boston, MA)
- …Translational Immunology, thorough familiarity and experience with the principles of drug development to ensure compound transition along the pipeline, management ... scientific excellence in Translational Immunology with a rich understanding of drug development, leadership, recruitment capabilities, management skills to direct a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The primary responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical ... Pharmacology) studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute to regulatory and KOL meetings.… more
- Merck & Co. (Rahway, NJ)
- …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 speak ... marketed products throughout the entire life cycle of the drug .Represent GRACS within our company's internal committees to provide...have not been vaccinated against COVID-19 and an essential function of your job is to call on external… more
- Merck & Co. (Boston, MA)
- …and molecular design scientists who employ state of the art capabilities to drive drug design and development across the globe.- We are seeking a passionate people ... leader and accomplished computational drug hunter to lead a team of talented computational...have not been vaccinated against COVID-19 and an essential function of your job is to call on external… more
- Merck & Co. (North Wales, PA)
- …of generating early clinical development plan and Investigational New Drug applications;-Developing clinical development strategies for investigational or marketed ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipating in internal and joint… more
- Merck & Co. (Rahway, NJ)
- …of generating early clinical development plan and Investigational New Drug applications.Developing of clinical development strategies for investigational or marketed ... to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Merck & Co. (Rahway, NJ)
- …coordinates, and provides biostatistical leadership and support for related drug /vaccine projects in CMC Statistics.Interacts with our company's Research ... analyzing CMC-related studies, and in coordinating other statistical activities for drug /vaccine projects.-This position may serve as a statistical lead in project… more
- Merck & Co. (Rahway, NJ)
- …Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and development (MIDD) to routinely enable efficient ... drug discovery/development and/or regulatory decisions. The Pharmacometrics group within...have not been vaccinated against COVID-19 and an essential function of your job is to call on external… more
- Merck & Co. (Durham, NC)
- …Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, ... business objectives even through adversity. This role will support drug substance manufacturing/sterile supply in regulated, clean room environments complying… more
- Merck & Co. (Rahway, NJ)
- …a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for...have not been vaccinated against COVID-19 and an essential function of your job is to call on external… more
- Merck & Co. (Rahway, NJ)
- …facility which is responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and ... a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) drug substance lab and the Specialist will become a...have not been vaccinated against COVID-19 and an essential function of your job is to call on external… more
- Merck & Co. (Rahway, NJ)
- …& Respiratory, thorough familiarity, and experience with the principles of drug development to ensure compound transition along the pipeline, management experience, ... excellence in Translational Cardiopulmonary with a rich understanding of drug development, leadership, recruitment capabilities, management skills to direct a… more
