- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mid-term, long-term). These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical Operations, ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategy. Responsibilities - Accountable for developing… 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)
- …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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... About the Department Our East Coast Global Development Hub brings together the best minds in...internal stakeholders Perform or supervise regulatory review of all clinical and nonclinical documents for submissions, eg, clinical… 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)
- …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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP ... aid in target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead,… 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)
- …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)
- … 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)
- …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 ... 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
- Insmed Incorporated (Bridgewater, NJ)
- …for Millennials™ lists.OverviewWithin the Translational Bioanalytical Sciences (TBS) group of Clinical Development , the role focuses on LC-MS/MS of small ... , nonclinical and biomarkers studies. This translational role resides within the Clinical Development organization, works closely with colleagues in other… 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
- Bristol Myers Squibb (Princeton, NJ)
- …trials and lead the clinical development team. Experience in early clinical development of neurodegenerative and/or neuropsychiatric indications is a ... careers.bms.com/working-with-us . The Director will be the clinical lead to progress early clinical...and/or neuropsychiatry is a plus. **Functional Area Description** The Early Clinical Development function is… more
- Bristol Myers Squibb (Princeton, NJ)
- …lead the clinical development teams. Extensive experience in early clinical development of neurodegenerative and/or neuropsychiatric indications is ... . The Senior Director will be the clinical lead to progress multiple early ...and/or neuropsychiatry is a plus. **Functional Area Description** The Early Clinical Development function is… more
- J&J Family of Companies (New Brunswick, NJ)
- Director , Early Development Leader - Hematology, Oncology Data Sciences & Digital Health - 2406180587W **Description** Johnson & Johnson's Innovative ... + Serve as primary business leader for Data Science & Digital Health for Early Development programs for robust Hematology Oncology portfolio. + Serve a… more
- J&J Family of Companies (Titusville, NJ)
- …to CP colleagues on hands-on aspects of clinical pharmacology. + Drive early alignment on key development questions where CP principles could be applied. ... Associate Director , Clinical Pharmacology and Pharmacometrics -...Leader is responsible and accountable for developing compound specific Clinical Pharmacology strategy for the development of… more
- Sanofi Group (Bridgewater, NJ)
- …plan strategies + Manage CRDs and Clinical Scientists within project and across the Early development team if needed + Lead/Act as a mentor for other CRDs ... **Principle Clinical Research Director - Gastronenterology** The...Regulatory and other key functional representatives **Key responsibilities include:** Clinical development plan strategies: + Clinical… more
- J&J Family of Companies (Titusville, NJ)
- …Janssen Research & Development , LLC is recruiting for an Associate Director , Clinical Pharmacology and Pharmacometrics (CPP) to be located in Spring ... Associate Director , Clinical Pharmacology and Pharmacometrics -...of innovative methods to preclinical research, translational sciences and clinical development . + Attend governance meetings, as… more
