- Formation Bio (New York, NY)
- …be part of that journey: As a key member of the team, based on your clinical development experience you will be responsible for providing medical input into our ... Development product assessment strategy and execution, lead the development of the Clinical Development Strategy and Plans, including protocol … more
- Lupin Pharmaceuticals (Coral Springs, FL)
- OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or ... projects, and clinical -regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development : Design and execute clinical … more
- Merck & Co. (Upper Gwynedd, PA)
- …new or marketed Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will ... manage the entire cycle of clinical development , including study design, placement, monitoring, analysis, regulatory reporting, and publication. --… more
- Insmed Incorporated (NJ)
- …CMOs, CROs, 3PLs, IXRS/IRT vendors and other third-party providers in alignment with clinical development and Clinical Operations timelinesFoster and manage ... plans, contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of clinical supply budgets and global… more
- Merck & Co. (North Wales, PA)
- …expected to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure life-cycle management. This role demands ... journals. The Clinical Director will also contribute to establishing Vaccine Clinical Development Strategies and executing short- and long term research… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... product development process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human health), and balancing… more
- BeOne Medicines (Emeryville, CA)
- The Senior Director, Clinical Development , Solid Tumors will support BeOne Clinical and Medical assets by successful execution of clinical development ... and execution. Specifically, the incumbent will work closely with colleagues in clinical development , program leadership, biometrics, clinical operations,… more
- Merck & Co. (MA)
- …, the Senior Clinical Director will manage the entire cycle of clinical development , including determination of appropriate disease indications to pursue and ... and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications.Providing clinical… more
- Merck & Co. (Boston, MA)
- …area. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director ... will manage the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring,… more
- Merck & Co. (North Wales, PA)
- …marketed Neuroscience Medicines. Our company's Neuroscience Medicines span all phases of clinical development (pre- clinical to post-licensure). With a focus ... , the Senior Director will manage the entire cycle of clinical development , including study design, initiation, execution,-monitoring, analysis, regulatory… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... and external to GCS and serves as the GCS spokesperson at clinical development related meetings (ie, Clinical Trial Teams) and product- development… more
- Insmed Incorporated (NJ)
- …staff (CRAs, and CTAs) by demonstrating leadership competencies.Works collaboratively with Clinical Scientist, Clinical Indication/ Development Lead, and ... CROs and other specialty vendors is essential.Thorough understanding of the drug development process and clinical trial execution, including ICH/GCP requirements… more
- Merck & Co. (Rahway, NJ)
- …globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the ... product development process & connectivity between functions supporting pipeline (ie clinical development , CMC, supply chain, & human health), and balancing… more
- Merck & Co. (Rahway, NJ)
- …Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers into clinical development across all therapeutic areas and all phases ... of clinical development at our Research & Development Division . TMB laboratories leverage a diverse array of technologies to develop biomarker assays to… more
- Eisai, Inc (Nutley, NJ)
- … Pharmacology will be relied upon to act independently, within a highly-matrixed clinical development organization and must have the experience and conviction to ... programs according to established design principals and integrates them into the Clinical Development Plan (CDP) and Drug Development Plan (DDP)Leads the … more
- Eisai, Inc (Nutley, NJ)
- …members.Requirements Bachelor's or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development or ... and oncology, with a strong emphasis on research and development . Our history includes the development of...your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for… more
- Insmed Incorporated (NJ)
- …and cross functional teams. This individual will provide scientific support to clinical development and operations, regulatory and quality assurance teams, as ... objectives: Develop, review, and revise departmental and corporate SOPs and processes.Provide clinical development and technical expertise in support of due… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a key member of the Global Product Team in collaboration with Clinical Development , Regulatory, Project Management, Biostatistics, Pharmacology, and other ... centered around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated… more
- Merck & Co. (Rahway, NJ)
- …clinical study related role.Required Skills: Accountability, Accountability, Biomarker Assay Development , Clinical Research, Clinical Sciences, ... and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Seattle reflect the full R&D continuum, from early research through late-stage clinical development . Here, we are building for the future, creating a ... Assurance/ Control, Chemical Development , Program Management, Regulatory, Analytical Development , Materials Management, and Clinical Supply Write, review,… more