- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Sr. Director , Clinical Safety MD, will lead the development and implementation of ... drug development, clinical pharmacology, and/or epidemiology.Oncology expertise requiredClinical safety experience with early phase oncology preferredMust have demonstrated… more
- Merck & Co. (Rahway, NJ)
- …drugs;-Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... dedicated colleagues while developing and expanding your career.The Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the planning… more
- Merck & Co. (Upper Gwynedd, PA)
- …-Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study ... changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice President in...- -Minimum of 3 year of industry experience in drug development or biomedical research experience in academia-- -… more
- Merck & Co. (Boston, MA)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs QA is ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director … more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical ... Medical Monitoring: Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and interpret safety signals, adverse… more
- Merck & Co. (Rahway, NJ)
- …and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject ... Job DescriptionJob Summary: -The Associate Director of Device Technology is a key leadership...global and site-specific projects related to combination products and drug delivery systems.Ensure that all activities are conducted with… more
- Merck & Co. (Rahway, NJ)
- …devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers ... Job DescriptionJob Summary: The Director , Combination Product Commercialization is a key leadership...stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and… more
- Merck & Co. (Durham, NC)
- …Drug Substance, Drug Product, and Analytics.-We are seeking an Assoc. Director to join our Live Virus Vaccine (LVV) team. The successful candidate will ... is seeking a highly motivated individual for the role of Assoc. Director , Engineering.- This role will provide end-to-end support of manufacturing science and… more
- Merck & Co. (Rahway, NJ)
- …GMP capability build for the production of clinical supplies of bulk biologic drug substance at a state-of-the-art Next Generation Biologics (NGB) facility at our ... 3-4 exempt and non-exempt employees to support bulk clinical manufacturing of biologic drug substances, and at times will require hands-on approach on the processing… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE the Director ... subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally.- The Packaging… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDir, Engineering - Director , Assembly and Packaging Platform Technical LeadershipReporting into the Executive Director Packaging Technical ... of key packaging and assembly platforms, with a focus on combination drug products such as prefilled syringes and autoinjectors.The Packaging Technical Operations… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of ... of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is...To provide SME guidance in support of small molecule drug substance and drug product container closure… more
- Genmab (NJ)
- …the CSRAttend trial and investigator meetings if/as neededCollaboration with Genmab Global Drug Safety :Participate in definition, review, and approval of data ... we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical...and technical progress within the field of biostatistics in drug development and advise of new methodologies that may… more
- Formation Bio (New York, NY)
- …pioneer the development of sophisticated models to predict clinical outcomes-determining drug efficacy, safety profiles, and optimal indications-to create a ... is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more… more
- Tris Pharma (Monmouth Junction, NJ)
- …(FDA), Drug Enforcement Administration (DEA), and Occupational Health and Safety Administration (OSHA) regulations, as well as all applicable company compliance ... in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The … more
- Genmab (NJ)
- …have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be based in our Princeton,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …experience in PV; required10 or more years of experience within Drug Safety /Pharmacovigilance experience, including both investigational and marketed products; ... oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction… more
- Merck & Co. (Rahway, NJ)
- …drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new… more
