- 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
- 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
- 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
- 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
- Merck & Co. (North Wales, PA)
- …GPAM Associate Director , Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering with team leaders to ... Advanced degree (eg, MS, MBA, Ph.D., PharmD) preferredExperience and knowledge of clinical drug development strongly preferred; including the different phases of… 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)
- …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)
- …- 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
- 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
- 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
- Eisai, Inc (Exton, PA)
- …pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on ... and oncology, with a strong emphasis on research and development . Our history includes the development of...scientific and technical resource to support several early to late stage manufacturing programs.This position will be responsible for… 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
- 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
- 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
- Catalent (CA)
- …Pharma Product DeliveryCatalent Pharma Solutions is recruiting for an Account Director , Pharmaceutical Softgel and Late -Stage Oral Solids. This position ... geography or a portfolio of accounts. As an Account Director , you will join our dynamic Business Development...of all sizes to advance new medicines from early development to clinical trials and to the… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …Operations (GCDO) leadership team.Essential FunctionsDirect all operational aspects of the Jazz late stage oncology clinical development pipelineAssure the ... visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Executive Director , Late Stage Oncology Clinical Operations will… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Late Development Team Lead (LDTL) is a critical role ... of products. The LDTL is accountable for leading the Late Development Team (LDT) in establishing and...on a global product(s) strategy, which integrates scientific rationale, clinical development , nonclinical development , regulatory,… more
