- Insmed Incorporated (San Diego, CA)
- …Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds ... of clinical studies, review & interpretation of clinical trial data, authoring clinical ...the company to external stakeholders supporting the conduct of clinical trials , including CROs, clinical … more
- Genmab (Plainsboro, NJ)
- …and dedicated Medical Director to be a part of our Global Clinical Development Team.The Medical Director will be accountable for the medical ... oversight of one or more clinical trials , medical review and communication of data,...key external presentationsProvide strategic input and development support for clinical plans and individual trial protocols. Interact… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... National Leaders/National Expert Panels for select clinical trials , in collaboration with Clinical Director...with other MA tools (expertise in clinical trial methodology and conduct, GCP principles, medical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of trial teams. Relationships This position reports to the Director , Clinical Operations. Essential Functions Collaborate with internal stakeholders and ... of Clinical Operations Collaborate with the Clinical Trial Leads and study teams with...vendor management Experience in rare disease, pediatric, and/or complex clinical trials preferred Ability to deal with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs...who contribute to the planning, conduct and reporting of clinical trials . Ensures business needs are met… more
- Merck & Co. (Rahway, NJ)
- …to lead our data management team in supporting the pharm and vaccine veterinary clinical trials . The ideal candidate will be responsible for overseeing the ... and confidentiality of data collected during laboratory challenges and clinical field trials . This role involves close...entry systems.Strong knowledge of GCP and GLP.Thorough understanding of clinical research and clinical trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the actual product Support all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... US East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs,...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and serving as the primary point of contact.Review and analyze data from clinical trials , post-marketing and other relevant sources for the prompt identification ... of safety signals. Review and evaluate serious adverse event reports from clinical trials or post-marketing for completeness, accuracy, expectedness and… more
- 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 improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …actual product Responsible for all areas related to patient safety in clinical trials Act as member of the trial safety group for dose escalation decisions ... US East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs,...) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …source of medical accountability and oversight for one or more clinical trials . Matrix management responsibilities across the internal and external network. ... medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the actual product. Responsible for all areas related to patient safety in clinical trials o Act as member of the trial safety group for dose escalation ... US East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs,...o Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …application of those principles to trial design, planning & conduct of clinical trials In-depth knowledge & direct experience/interactions with the FDA (or ... the planning & successful delivery of studies within the clinical trial portfolio. Assists in creating, leading...external partners relevant to the design & implementation of clinical trials improvement/innovation projects for CDO &… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and ... the strategy, development, effective execution of CMR role-specific/technical training (eg clinical trial -related, patient safety, therapeutic area leads, MSLs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HQ. Key internal relationships include Project Managers, Clinical Directors, Medical Affairs directors, HEOR Directors, Market Access director , Marking ... leadership Secure line management input and alignment from Executive Director and Vice President of Medical Affairs...of market needs and resource allocation Strong expertise in clinical trial methodology and conduct, and GCP… more
- Genmab (Plainsboro, NJ)
- …conduct of clinical trials in oncology. Proficiency in clinical data review and interpretation.Experience in translating medical / clinical information ... be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director of US Medical Affairs Solid Tumors Strategy will report to the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …members of the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology development and ... in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research...a focus on delivering results required- Experience with oncology medical strategies and clinical trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Research, secondary data analytics, searching and reviewing scientific literature, clinical trial data, journal studies Progressive demonstrated business ... to maximize your potential with us? The Position As the Associate Director of Strategic Market Insights, the functional responsibilities include leading analyses of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements ... acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements.… more
