- 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)
- …supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly ... of statistical datasets that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation.The position is… 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 ... part in the unique opportunity to bring highly innovative pharmaceutical products through clinical development to market. The candidate is a team player, detail… 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
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position focuses on strategic activities impacting late - stage development therapeutic area (TA) projects to the direct benefit of project ... Clinical Study Report and filing completion timelines worldwide.Lead development of therapeutic areas- specific standard Tables, Listings, Figures (TLF)… 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
- 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 ... supporting CDx submissions to the FDA and other health authorities globallyFor late - stage programs, executes the Diagnostic development strategy for… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased ... complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ad hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased ... complexity including post marketing projects and those involving 3rd party development . This position partners with GRLs and Clinical Safety Pharmacovigilance… 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 ... 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
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- … groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late - stage clinical research Qualifications: 3-5+ years of biotech ... Medicine in the Development group is responsible for early clinical development of novel therapeutics, working in close collaboration with nonclinical and … more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** The Head of the Late - Stage Clinical Development organization is a member of the Organon Research and Development ... late - stage programs at Organon. + Oversight, direction, and execution of late - stage clinical development programs at Organon. + Co-chairing the… more
- Merck (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
