- 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 ... medical/ clinical queries from health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development, medical affairs, and… more
- BeOne Medicines (Emeryville, CA)
- …its vision and mission. Leveraging deep therapeutic and functional area expertise, the Clinical Operations Lead in Biotech Unit is accountable for the planning, ... budget, and oversight the execution of clinical studies of BTU assets, through partnering with execution...for annual budget and resource forecasts, as well as lead to define CST goals for the assets +… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Non- Clinical Operations Lead within the Non- Clinical Development Team (NCD), is responsible for operational ... function within the Translational Medicine and Early Development (TMED) team. Non- Clinical Operations Lead will report to the Non- Clinical Safety Assessment … more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The** **Position** The Director, Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical ... Medicine and Early Development (TMED) Department at Organon. The Clinical Pharmacology Lead also will be responsible for the rationale, study design… more
- Insmed Incorporated (San Diego, CA)
- … Clinical Development, you will support and work predominately with the Clinical Trial/Indication Lead (s) and Medical Monitor(s) for assigned protocols and/or ... Are you?About the Role:We're looking for an Associate Director, Clinical Scientist for the Gene Therapy Clinical ...Director, Clinical Scientist for the Gene Therapy Clinical Development team to help us expand what's possible… more
- Eisai, Inc (Nutley, NJ)
- …the development of Clinical Protocols to meet CDP objectives.Serves as Study Director/ Clinical Pharmacology Lead and drives the execution of the study from ... at least 5 years of pharmaceutical industry related experience as a Clinical Pharmacology Project Lead .A thorough understanding of global regulatory requirements… more
- Parexel (Columbus, OH)
- **PXL is seeking a clinical operations lead with expertise in clinical sample logistics and proficiency in computational programming to support the ... related to clinical study samples, data, kits, and logistics. - Lead cross-functional study teams, manage vendor relationships, and oversee clinical trial… more
- Insmed Incorporated (NJ)
- …staff (CRAs, and CTAs) by demonstrating leadership competencies.Works collaboratively with Clinical Scientist, Clinical Indication/Development Lead , and ... future of science, we're in. Are you?About the Role:The Clinical Trial Manager will be responsible for the management...responsible for the management and oversight of phase I-IV clinical trials, with a key focus on Phase 1-2a,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trained, following process and SOPs. The Director will ensure the Senior Director, Clinical Operations (Asset Lead ) is fully informed of the overall portfolio ... The Director can be an extension to the Asset Lead when needed and serve as an SME (Subject...will include providing innovative strategies to continuously improve Global Clinical Operations quality and metrics. IT will also include… more
- Formation Bio (New York, NY)
- …to high standards of quality, cost control, and on-time deliverables. Serve as the Operations Lead for clinical assets and associated studies. Step in as the ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …ensures accurate and complete study team list is maintained.-In partnership with the lead physician, Clinical Scientist and all study team members, accountable ... around rare diseases and immune disorders. SummaryThe Study Delivery Lead (SDL) leads the cross functional core and extended... (SDL) leads the cross functional core and extended clinical study team in end-to end delivery of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Job Summary: The Sr. Director, Clinical Safety MD, will lead the development and implementation of integrated ... key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments… more
- Merck & Co. (South San Francisco, CA)
- Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities ... investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development,… more
- Merck & Co. (North Wales, PA)
- …to lead a Product Development Team (PDT) through late-phase clinical development and into post-licensure life-cycle management. This role demands scientific ... Job DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries...boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and… more
- Merck & Co. (Rahway, NJ)
- …clinical strategy for novel Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early ... of preclinical discovery into compounds ready for assessment in large clinical populations.We are seeking a highly qualified physician-scientist with a proven… more
- Insmed Incorporated (NJ)
- …Clinical Operations timelinesFoster and manage strategic supplier relationships, lead vendor selection, performance monitoring, business review governance, and ... the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning and… more
- Formation Bio (New York, NY)
- …medical input into our Business Development product assessment strategy and execution, lead the development of the Clinical Development Strategy and Plans, ... than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of… more
- CSL Behring (King Of Prussia, PA)
- …make a meaningful difference worldwide. Could you be our next Senior Director, Global Clinical Program Lead , Cardiovascular? The job is in our King of Prussia, ... be accountable for the design and execution of the clinical strategy to support the development of a medicine,...required cross-functional Delivery Teams (DT)** This position is a " Lead Author" or "Contributing Author" for: **key study documents,… more
- Insmed Incorporated (NJ)
- …computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical /Manufacturing systems.Project lead experience preferred.Strong experience in ... and FDA/EU regulations:21 CFR Part 11, Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental… more
- Merck & Co. (North Wales, PA)
- …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
