- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical studies in late stage developmentLead and manage the multiple late development and/or transitioned asset Clinical Science Asset Leads ... be the Clinical Science Group Lead in late phase development in the Global ...Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical … more
- Merck & Co. (Rahway, NJ)
- …activities involving investigational compounds in Immunology. With a focus on late -stage development , the Senior Clinical Director will manage the entire ... the development of new compounds The Senior Clinical Director may: Oversee the Clinical...clinical trials in immunology therapeutic areas. Experience in late stage IBD trials and regulatory filing is preferred.Minimum… more
- Merck & Co. (Rahway, NJ)
- …multi-modality composition of matter manufacturing, testing, quality and supply processes from late clinical development through commercialization and uses ... momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug… more
- Merck & Co. (Rahway, NJ)
- …innovation and improve lives. -Position Description: Under the guidance of the Oncology Clinical Development Finance Associate Director , the Finance Senior ... financial and/or operational review with client areas being supported, including the Late Development Review Committee.Support project team decision making by… 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 developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical ...to be shared with KEEs; Frequent involvement in Business Development activities for late stage compounds; Involvement… 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, ... KOL interactions on a program-based need; Peripheral involvement in Business Development activities for late -stage compounds Involvement with in-licensing and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in data science / business intelligence / statistics role supporting drug development and/or post marketing in clinical research, pharmaceutical, CRO or ... end-to-end delivery of AI/ML projects (from business understanding, over hands-on development to dissemination), to ensure high quality deliverables are on time… 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 ... to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD degree, board certified/eligible and/or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …increased complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety ... Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects...may assist another Global Labeling Lead by managing labeling development or approval for either the US or EU.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …- Responsible, with limited supervision, for study activities assigned, eg for a clinical study: provide input on the development of study protocol (design, ... least 5 years of experience as statistician supporting drug development and/or post marketing in Clinical research,...More Years Experience in oncology Therapeutic Area and/or in late phase projects is preferred Travel Ability to travel… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in ... 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)
- …preferred- Knowledge of all phases of drug development , including early and late phase clinical development and submission preferred- Solid background in ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of companion diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in ... 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for the future, ... 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
- J&J Family of Companies (Raritan, NJ)
- Director , Late Development Clinical Lead - Retina - 2406173830W **Description** Johnson & Johnson is recruiting for a ** Director , Clinical Leader ... strategic, clinical , and scientific support through all phases of clinical development . The Director will have broad responsibilities including: *… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …studies in late stage development . Lead and manage the multiple late development and/or transitioned asset Clinical Science Asset Leads including ... be the Clinical Science Group Lead in late phase development in the Global ...Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical… more
- Bristol Myers Squibb (Summit, NJ)
- …early clinical assets from first-in-human through proof-of-concept and will prepare the clinical development plan, design clinical trials and lead the ... development teams. Extensive experience in early clinical development of neurodegenerative and/or neuropsychiatric indications...of BMS + Partner and interact with colleagues from Late Development to assure a seamless transition… more
