- Merck & Co. (Rahway, NJ)
- …pre- clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.Providing ... involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the entire cycle of … more
- Merck & Co. (Rahway, NJ)
- …(Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT),-and Labeling ... drug development experienceM.D. with minimum of 3 years relevant drug development experience or clinical experiencePhD/PharmD with minimum of 5 years… more
- Merck & Co. (Rahway, NJ)
- …recommendations regarding commercialization strategies, portfolio prioritization and sourcing, clinical development /research strategies, and Business ... innovative medicines that help people across the globe. Competitive Intelligence Director Individual will be responsible for providing Competitive Intelligence (CI)… more
- Merck & Co. (Rahway, NJ)
- …launch and after.The candidate will work closely with value and Implementation teams under clinical development -to ensure all clinical trials include the ... member for Value and Implementation teams and ad-hoc member for Pharmaceutical Development / Early Development teams.Monitor Oncology global competitors and… more
- Merck & Co. (Rahway, NJ)
- …benchmarking, and recommendations for commercialization strategies, portfolio prioritization, clinical development /research strategies, and Business ... Development initiatives.Partnering with discovery and clinical colleagues to shape research programs.Analyzing select competitor activities through strategic… more
- Catalent (New York, NY)
- …pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... a part of the Global Nutritional & Beauty Business Development Team reporting to the Regional Director ...Business Development Team reporting to the Regional Director Beauty Softgels North America, and responsible for managing… more
- Merck & Co. (Rahway, NJ)
- …responsible for interfacing with scientists who are manufacturing drug substance to support early clinical studies, scaling up new chemistries, and exploring new ... potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned… more
- Merck & Co. (Rahway, NJ)
- …the Development and Commercialization Team (DCT). Additionally, maintain engagement with Early Development Teams (EDT) and Product Development Teams ... Job DescriptionDevice Development Principal Scientist - Device Development Lead ( Director Equivalent) Our company's Device Development (DD) Team designs,… more
- Merck & Co. (Rahway, NJ)
- …responsible for interfacing with scientists who are manufacturing drug substance to enable early clinical studies, scaling up new chemistries, and exploring new ... Specialist -Operations Support position will report to the Associate Director , Engineering and will be a member of the...for manufacturing drug substance to supply material for both development work and clinical studies in our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as with early -stage compounds required- Excellent understanding of the clinical development and life cycle of oncology medicines required- Strong ... functions including but not limited to Commercial, Marketing, Medical, & Clinical Development ,ResponsibilitiesGlobal Market Access Strategy- Lead the … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(short-term, mid-term, long-term)These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategyResponsibilities - Accountable for developing the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities.SummaryThis position supports early phase oncology development and leads complex studies in ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory, ... and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... and Pharmacovigilance (CSPV) must be embedded in R&D as early as possible. This led us to create the...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... eg, NCI.Scientific, Program Related: Integrated Study Team (IST) Representative: Creates early development plan and contributes to overall development… more
- Insmed Incorporated (Bridgewater, NJ)
- …Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role ... the company in outside groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play ... Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launchLeads CDx Partner evaluation and selection activities… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials preferred- Knowledge of all phases of drug development , including early and late phase clinical development and submission preferred- Solid ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Insmed Incorporated (Bridgewater, NJ)
- …Technical Operations liaison to the Insmed research team for lead optimization and early development programs. This position will be the dynamic cross-functional ... interaction between lead optimization research and early CMC development .Responsible for the management of API/Intermediate/RSM manufacturing operations at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …implementation of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play ... Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development through CDx approval and launch- Leads CDx Partner evaluation and selection,… more
