- 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 ... part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …developing the Global Clinical Science Strategy and delivery of clinical studies in late stage development . Lead and manage the multiple late ... be the Clinical Science Group Lead in late phase development in the Global ...of Ph1-Ph3 studies, including assets transitioning from early to late stage . preferred TravelAbility to travel up… 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 ... The Director will work closely with cross-functional project teams, including Clinical Development , Clinical Operations, Biometrics, and Regulatory… 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 ... dose escalation decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's… 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 ... to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. Relationships… 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
- Merck & Co. (Rahway, NJ)
- …Experience and Skills:Experience bringing drugs through various stages of clinical development , with an emphasis on late - stage developmentExperience with ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Respiratory will focus on...across the enterprise to ensure operational excellence in the late development of assets within the Respiratory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position serves as the Clinical Safety Scientist Lead for a large, late - stage program or multiple early- stage programs, in order to proactively ... Clinical Safety Scientist Lead for a large, late - stage program or multiple early- stage ...degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …material 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development , maintenance, ... data submissions and relative processes. Working knowledge of early and late - stage submissions per local/regulatory requirements, demonstrated ability to… 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)
- …and immune disorders. Summary Oversees early- stage trials, such as global clinical development program for multiple product candidates with one or more ... with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections...KOLs; Thought partner with Ext Scientific Affairs on Business Development activities for late stage … 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 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)
- …for patients.The EDSA leads a large investigator-initiated studies program in partnership with late - stage development teams in Medical Affairs while also ... (EDSA) maximizes meaningful bi-directional scientific exchange with the worldwide clinical and academic community to positively impact Research and...supporting early- stage development teams. The role also partners with Medical Affairs… more
- Eisai, Inc (Nutley, NJ)
- …value data to support Eisai business. This role primarily focuses on late - stage pipeline and marketed products, interfaces with cross-functional teams including ... EMRs, patient charts, administrative claims datasets.Previous RWE experience in clinical /medical development , and interactions with regulatory authorities is… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and communicate progress and risks toward the timely testing of biomarkers in clinical development programs. The individual will be directly involved in ... (mainly US and Japan) with biomarker scientists, translational science leads and clinical development staff in the timely deployment of high-quality biomarkers… more
- Merck & Co. (Rahway, NJ)
- …are seeking an energetic and motivated individual to be a core member of an Early- Stage Development or Late - Stage Development Team, partnering ... Global Project and Alliance Management (GPAM) sits in the research & development organization at Merck (Merck Research Laboratories, or MRL). The Project, Portfolio… more
- Eisai, Inc (Nutley, NJ)
- …patient charts, administrative claims datasets.Previous RWE experience in medical or clinical development , and interactions with regulatory authorities is ... and oncology, with a strong emphasis on research and development . Our history includes the development of...to support Eisai business. This role primarily focuses on late - stage pipeline and marketed products, interfaces with… more
- Merck & Co. (Rahway, NJ)
- …talented scientists and engineers to advance the biologics pipeline from early- to late - stage development .Partner with groups in both research and ... To achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development , Analytical, Formulation, and Commercial Manufacturing while… more
