- Merck & Co. (Boston, MA)
- …research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations) for the design and execution ... specialists to advance novel therapeutics from preclinical development into clinical developmentAs a key member/ leader of an...of early clinical development strategyTaking a lead role in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) or major ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...valid clinical interpretation of study results as Clinical Study Leader , medical monitor or regional… more
- Insmed Incorporated (San Diego, CA)
- …Medical Director of Ophthalmology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the ... from first-in-human trials, through to full development.Serve as the therapeutic area lead of the ophthalmology clinical development team, partnering closely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Safety Surveillance and other cross functional teams. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead /Director/Senior Director - Safety Surveillance, US East… more
- Merck & Co. (Rahway, NJ)
- …optimize labeling and obtain shortest time to approval by regulatory agencies.Functions as global regulatory lead assigned to programs where the compound is ... final approval of all submissions and associated documentation.Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …also interacts with other therapeutic area leaders and joint Alliance partners.Responsibilities: Lead a multidisciplinary Global Regulatory Team (GRT) to develop ... leadership and set direction, acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory… more
- Merck & Co. (South San Francisco, CA)
- …research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).Provide clinical pharmacology ... of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development ... around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the ... around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to the… more
- Merck & Co. (Rahway, NJ)
- …execution of Phase 1-4 clinical studies. Under the direction of the Program Lead , you will collaborate with global , cross -functional team members including ... Responsibilities Responsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical scientist on the clinical … more
- Merck & Co. (Rahway, NJ)
- …final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single ... point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS)...delivery of targeted product labelingProvide expert advice as the Global Regulatory Lead to Product Development Teams… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …creating business results with impact on VP/CVP level. Motivated, collaborative, and science-driven global safety expert who would lead the ongoing assessment of ... HAs, ECs, DMCs, and Academia. Line management of Senior Global Safety Lead (s), Global Safety...life sciences/pharmacy nursing degree with 15+ years' experience in global safety surveillance and/or clinical /drug development Excellent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we ... an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we ... an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of clinical supplies across the DSI portfolio. This role as CSO ( Clinical Supply Planning and Operations) Project Lead is primarily responsible for ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...rare diseases and immune disorders. Summary NOTE: This Project Lead Role is an Individual Contributor and sits at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) ... global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the… more
- Merck & Co. (Rahway, NJ)
- …require: Outstanding leadership in market assessment, disease state strategy, product clinical development, product strategy, market development, thought leader ... Job DescriptionWe are currently recruiting for a Global Marketing Director for metastatic lung cancers. Our Marketing team is passionate about bringing our medicines… more
