- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of ... the Senior Director , GMA Oncology ADC (Global Medical Affairs ...program medical strategies and for leading select medical affairs projects within a specific compound or indication.ResponsibilitiesLeads the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …throughout the product's lifecycle and across different indications.Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance ... processes, and on Joint Alliances.Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global… more
- Merck & Co. (North Wales, PA)
- …including the related SOPs and Execution resources. The incumbent is accountable to Sr. Director of Business Process and Systems with input from VP, CSRM as needed, ... contributing functional areas and process governance committees. Works with Sr. Director for Business Process and Systems, -CSRM to develop and implement… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …TA priorities and business needs. Relationships This position may report into the Field Director , Medical Affairs (or in smaller TA's directly into the TA head). ... They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison field team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science (CS) ... in one or several programs. Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility ... clinical development team, partnering closely with heads of clinical operations, toxicology, regulatory affairs , commercial, pharmacovigilance, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the ... management or leading change management initiatives preferred- Prior experience in clinical development, Medical Affairs , or Global Marketing preferred-… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …interact with the Companion Diagnostics Lead, Non- Clinical Research, Medical Affairs and other stakeholders to support the program . Other responsibilities ... non- clinical research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … will lead the execution and lifecycle management of Global Medical Affairs ' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence ... to Good Clinical Practices (GCPs), relevant Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations, EU Directives, and International… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non- clinical ... execution plans across and effective alignment within (eg with translational research, clinical operations, clinical development, medical affairs CSPV and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the ... and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory… more
- Merck & Co. (North Wales, PA)
- …that could include Executive Director , Senior Director , or Director level personnel responsible for oncology clinical development programs or projects. ... closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …department at Novo Nordisk, Inc. RelationshipsThe fellow will report to the Fellowship Director throughout the two-year program and will also have a reporting ... Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning & Development, Clinical Trial Management, and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program . The Principal Medical Writer will provide high level strategic ... will work closely with cross-functional project teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …deliverables that support the clinical development and regulatory requirements of a clinical program . Relationships The Senior Medical Writer reports to a ... Director of Medical Writing. The Senior Medical Writer is...from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions ... healthcare providers, key stakeholders and policymakers. Our Market Access and Public Affairs professionals ensure that the latest therapies and products reach the… more
- Arcellx (Redwood City, CA)
- …diverse set of views and backgrounds. How You'll Make a Difference As our Senior Director , Clinical Regulatory Affairs , you'll lead and drive Arcellx's ... market. The "Fine Print" - What You'll Do Develop and execute global clinical regulatory strategies. Lead program teams in preparing regulatory submissions… more
