- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).ResponsibilitiesLead the authoring, revising, and managing ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments + Authors… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- The Associate Director , Strategic Sourcing, Clinical Category Lead, will lead the Strategic Sourcing efforts for R&D categories including CROs, study ... monitoring, site management and clinical trial support suppliers across all phases...to provide a value-added service to the organization. The Associate Director , Strategic Sourcing, Clinical … more
- Bristol Myers Squibb (Princeton, NJ)
- …oncology, immunology, cardiovascular and neuroscience. This group integrates laboratory science, clinical trial /biomarkers and asset development as well as ... stage drug development and activities required for and related to clinical trial initiation, maintenance and completion + Strong verbal and written communication… more
- Bristol Myers Squibb (Princeton, NJ)
- …biology, mechanism of action, and predictive biomarkers in our late-stage clinical oncology portfolio. Ideal candidates will possess a strong scientific background, ... communication skills, and experience working in a matrixed industrial environment. The Clinical Biomarker Lead role will be responsible for development and execution… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 years ... While not essential, prior personnel management experience, will support position at entry ( Associate Director / Director ). + An advanced understanding of drug… more
- Bristol Myers Squibb (Princeton, NJ)
- …Patients, and Payers in accordance with local regulations. **Key Responsibilities:** The Associate Director of Medical Communications is accountable for the ... aligned medical communications plans; adjust communications plans in accordance with clinical trial results/milestones and changes in the healthcare landscape… more
- Sumitomo Pharma (Trenton, NJ)
- …marketed products. + Conduct safety surveillance over product life cycle, reviewing clinical trial and post-marketing Individual Case Safety Reports (ICSRs), ... highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate ...safety of clinical trials, including monitoring of clinical trial safety and laboratory data. +… more
- Ascendis Pharma (Princeton, NJ)
- …publication plan for one or more rare disease therapeutic areas, the Associate Director of Global Scientific Publication Planning oversees the planning, ... abstracts, posters, oral presentations, manuscripts, and publication extenders. The Associate Director will collaborate cross-functionally to understand the… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …needs and nutraceutical products for the maintenance of everyday health. **Job Summary** The Associate Director of HCP Marketing - Rare Renal will report to the ... Director of HCP marketing and be an integral member...cross-functional team members. + Become an expert on the clinical trial data, the marketplace, and HCP… more
- Grifols Shared Services North America, Inc (Trenton, NJ)
- …safety data (toxicology) and use this information to develop safety mitigation strategies in clinical trial design + Serve as a key part of the cross-functional ... than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy... research experience with at least 5 years of clinical document production and/or clinical trial… more
- Bristol Myers Squibb (Princeton, NJ)
- …and success of the BMS R&D pipeline. This role may report into Director , Clinical Data Management or Associate Director , Clinical Data Management. ... * Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects * Responsible for… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …through early and/or late phase development. The Senior Manager reports to the Associate Director , Clinical Sciences and collaborates closely with Medical ... author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists with and may author/review… more
