- 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)
- …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)
- …GCO Leadership, GCO Study Management, CROs, Procurement, Legal, Compliance, Finance, Clinical Development , Global Project Management, and Functional Quality ... Financial Reporting & Strategy position provides leadership in strategy and process development for Global Clinical Operations (GCO) to ensure the implementation… 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)
- …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)
- …multidisciplinary pharma/diagnostic development team.- Knowledge of the IVD and/or clinical development process is a plus.- Knowledge of molecular ... 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… 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)
- …initiatives, novel technology or techniques in the context of clinical development . requiredProven change management experience required.Proven strategic ... Oversight Associate Director plays an integral role in the strategic development , oversight, and execution of global monitoring conduct across the DS portfolio.… 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
- 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
- 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
- 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
- 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)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...with SDEA requirements. Relationships This position reports to the Director , Case Review & Compliance Reporting within Patient Safety.… 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
- Bristol Myers Squibb (Princeton, 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
- J&J Family of Companies (Trenton, NJ)
- …Family of Companies, is recruiting for a Director /Senior Director , Clinical Rseearch Physician for ** Late Development Oncology** . The preferred ... Medical Director / Sr. Med Director , Clinical...Leads execution of research programs for an area of clinical development to meet research objectives, support… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …to End strategic sourcing solutions for commercial supply requirements from pre-launch ( Late Development /Phase 2b) through the product life cycle. Role ... to End strategic sourcing solutions for commercial supply requirements from pre-launch ( Late Development /Phase 2b). + **Own global category strategy** … more
- J&J Family of Companies (Raritan, NJ)
- …with Sr. Disease Directors, regional and cross-functional teams, including R&D, clinical development , regulatory affairs, and marketing, to ensure seamless ... **Description** Johnson & Johnson, is recruiting for a Sr. Director , Portfolio Strategy & Early Development in... and implementation of key components of the early/ late stage and portfolio commercial strategy as appropriate, including… more
