- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will ... in Clinical Development, Asset & Portfolio Management, Global Clinical Operations, BDM and DLT members....Strategy and delivery of clinical studies in late stage development. Lead and manage the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will ... Therapeutic Area strategy that will bring forth programs to successful approval and registration. Lead late -stage development for our company's assets in this TA… more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/ Late Development Statistics, ... and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment,… 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, creating a ... regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase… more
- Merck & Co. (Boston, MA)
- …governance Dose Day.Establish and own Immunology strategy with other TA Heads (Discovery/ Late -Stage Clinical Development). Lead key technical reviews for ... network of key cross-functional partners both within TMed, Discovery Research, and Global Clinical Development.-The candidate will be expected to understand our… more
- Merck & Co. (Rahway, NJ)
- …extensive network of key cross-functional partners both within TMed, Discovery, and Global Clinical Development.-The candidate will be expected to understand the ... Therapeutic Area and strategy, bridging the continuum from Discovery Research through Late -Stage Clinical Development.- The AVP provides strategic oversight for… 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 ... introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and Operations Technology in Biopharma… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … global labeling issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either the ... Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- Lundbeck (Bothell, WA)
- …on methods to determine the potency of drug product for early through late -stage clinical development programs. The successful candidate will have a thorough ... with responsibility for potency methods for all development programs (from early to late phase clinical development) Author and review SOPs, development reports,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead .Responsibilities:Medical Monitoring Planning (MD Only): For ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- …:Address operational challenges that require strategic solutions, resulting in improved Clinical Study Report and filing completion timelines worldwide. Lead ... support of internal stakeholder groups including the Outcomes Research and Clinical Safety organizations. Lead and actively contribute to departmental strategic… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …management activities across the study duration.- Operational Excellence and Innovation May lead and/or participate in Global Evidence Generation initiatives to ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …the successful implementation of these assays and execute on biomarker strategies in clinical trials across early and late -stage clinical development.Liaise ... Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical Biomarkers, ... data services they provide to support drug development processes and global submissions.This position provides expertise within Data Management by partnering with… 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, creating a ... About the Department Our East Coast Global Development Hub brings together the best minds...on a variety of assignments and special projects May lead moderately complex projects within own department or that… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase… 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 background in ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Novo Nordisk Inc. (Boulder, CO)
- …Watertown and Cambridge reflect the full R&D continuum, from early research through late -stage clinical development. Here, we are building for the future, ... a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while...in Boulder, CO and reports to the Lab IT lead in Lexington, MA. Additional internal stakeholders include IT… more
