- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase... related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... but are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a...and implement changes as appropriate at the trial level, program level, TA level and department Level.Performs tasks with… more
- Catalent (San Diego, CA)
- …Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a member of the Site Leadership Team, you will partner with ... manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit...of quality issues to Site Leadership Team and QA senior management. Lead programs for: QA department budget,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical program planning and execution (from study ... and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program … more
- Lundbeck (Miami, FL)
- …airport. Territory consists of Florida, Georgia and Puerto Rico POSITION SUMMARY:The Senior MSL, Neurology will apply advanced field based medical and scientific ... medical strategies for Lundbeck compounds. Maximizes and leverages thought leader relationships by identifying mutually beneficial opportunities that meet the… more
- Merck & Co. (Rahway, NJ)
- …biostatistical support for related drug/vaccine projects in Late Development Statistics. Lead the interaction with Clinical , Regulatory, Statistical Programming, ... for the benefit of patients and global human health. Responsibilities :Serves as a statistical lead in project teams. Lead , develops, coordinates, and provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes ... in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with key… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the ... management regarding the potential impact of toxicology results on Program and Clinical /Regulatory strategy.Author nonclinical sections in regulatory submission… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible...in Boulder, CO and reports to the Lab IT lead in Lexington, MA. Additional internal stakeholders include IT… more
- Merck & Co. (Boston, MA)
- …community, research conducted in our laboratories spans exploratory biology through early clinical development and is an integral part of our company's powerful ... while advancing your career.Job Description:Our Company is currently seeking exceptional Senior Scientist peptide chemists to join our Boston site's highly… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionFLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to ... drug products. Operational leadership of the FLEx complex is shared across two co- leader roles, and includes operations that support end-to-end GMP clinical … more
- Merck & Co. (South San Francisco, CA)
- …site-specific conjugation methodologies for preclinical in-vitro and in-vivo studiesAct as a leader in the laboratory, executing on program and chemistry ... research conducted in our new laboratories spans exploratory biology through early clinical development and is an integral part of our Company's powerful world-class… more
- Aequor (Thousand Oaks, CA)
- …for candidates who are the stronger the better, can be a hands off leader , candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal ... understanding of systems for sharing and collaboration ; excellent communication skills to work with cross- program resources and with all levels of management. more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …- Head. Interacts frequently in collaboration with internal management and senior level managed markets customer representatives. Interacts internally with team ... initiatives including but not limited to KOL development, advisory boards, clinical communications and medical education programs Responsible for the development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …development plan. This position is accountable for partnering with the Global Team leader as the Project Management lead on drug development projects. This ... supporting divisional and departmental level objectives and may also lead a non-project initiative in support of these objectives....execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Franchise leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of ... point person for all GxP matters for the Global Program Head and the Global Program Team....Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence,… more
- Merck & Co. (Boston, MA)
- …and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
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