- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects.- Accountability predominantly ... of statistical databases that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation.The position is… more
- Merck & Co. (North Wales, PA)
- …human health. This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include ... of statistical datasets that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation. The position… more
- Merck & Co. (North Wales, PA)
- …across the globe. Working with the Asset Development Team (ADT's), early- & late - stage clinical development teams, the Biomarker (BMx) leads will ... development for our Company's Oncology programs. Working with early- and/or late - stage clinical development teams, he/she will have the opportunity… more
- Merck & Co. (Boston, MA)
- …Medicine (TMed) Immunology strategy, bridging the continuum from Discovery Research through Late - Stage Clinical Development .-The AVP provides strategic ... governance Dose Day.Establish and own Immunology strategy with other TA Heads (Discovery/ Late - Stage Clinical Development ).Lead key technical reviews for… more
- Merck & Co. (Rahway, NJ)
- …Respiratory Therapeutic Area and strategy, bridging the continuum from Discovery Research through Late - Stage Clinical Development .- The AVP provides ... the Cardiovascular & Respiratory portfolio (discovery therapeutic area review, early and late - stage clinical governance), and fully supportive of… more
- Merck & Co. (Rahway, NJ)
- …BDSC.Scope includes:Participates in and/or leads cross-divisional technical teams focusing on late - stage clinical process development , characterization, ... and/or vaccine molecules at the pilot or commercial scale.Prior experience in late - stage process development , process characterization, process performance… more
- Lundbeck (Bothell, WA)
- …a focus on methods to determine the potency of drug product for early through late - stage clinical development programs. The successful candidate will ... for potency methods for all development programs (from early to late phase clinical development ) Author and review SOPs, development reports, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late - stage clinical development . We are building for the ... 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
- 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 cycle of clinical development , including determination of appropriate disease indications to pursue...clinical trials in immunology therapeutic areas. Experience in late stage IBD trials and regulatory filing… more
- Novo Nordisk Inc. (Boulder, CO)
- …Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late - stage clinical development . Here, we are building for ... About the Department Our Boston Research & Development hub, anchored in the greater Boston area,...experience includes: Experience in a biotechnology, life sciences, or clinical IT systems analyst or computer programmer role Experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … studies in late stage developmentLead 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 ...including training, data review tools, etc.Standing PRG reviewer for mid-to- late - stage asset protocolsCore or extended member on… more
- Insmed Incorporated (Bridgewater, NJ)
- …in outside groups.Contribute to the strategic development of early and late stage clinical programs.QualificationsRequires an MD or PharmD degree, ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director, Clinical Development will play an important role in working with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Area; Reviews content to be shared with KEEs; Frequent involvement in Business Development activities for late stage compounds; Involvement with in-licensing ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …work experience required- 15+ years industry or related experience required- Extensive early/ late stage drug development experience ideally including time ... establishing area-relevant standards, (v) encouraging innovation.Build strong relationships with clinical development , clinical sciences, regulatory,… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development , Analytical, Formulation, and Commercial Manufacturing while ... to design, develop and execute robust processes in support of early- to late - stage biological products. You will apply rigorous scientific principles to solve… more
- Merck & Co. (Rahway, NJ)
- …To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development , Analytical, Formulation, and Commercial Manufacturing while ... team members to design and develop robust processes in support of early- and late - stage biologics. You will innovate to support our company's biologics pipeline… more
- Merck & Co. (Rahway, NJ)
- …to upstream processing and recombinant expression of drug candidates in early- and late - stage development .-Responsibilities include but are not limited to:As ... robust and scalable upstream processes for biologics in different stages of clinical development , 2) process characterization and regulatory filings for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for KOL interactions on a program-based need; Peripheral involvement in Business Development activities for late - stage compounds Involvement with ... interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development ... reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as… more
- Merck & Co. (Rahway, NJ)
- …planning and execution of strategies for Digital/Technology enablement of late - stage drug substance and product (LM/SM/Vaccine), process development , product ... planning and execution of strategies for Digital/Technology enablement of late - stage drug substance and product (LM/SM/Vaccine), process development , product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diverse external providers for clinical trials, companion diagnostics trials, clinical development , and regulatory submissions. The position will perform ... Programs.Lead the Data Management aspects of diagnostics across Daiichi's early and late - stage oncology portfolios through close collaborations with internal and… more
