- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi Sankyo governance processes, ... acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory CMC and other appropriate groups… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs , Evidence Generation ... Evidence Plans (IEP) with the Alliance Partner.- As a member of Global Medical Affairs Team (GMAT, or Joint Medical Affairs Team for Alliance compounds) and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Affairs Oncology (GMA), ADC, under the direction of the Senior Director , GMA Oncology ADC (Global Medical Affairs team lead for compound), is responsible ... medical education and other scientific exchange activities in alignment with the Senior Director , such as scientific symposium and medical congresses, within… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical ... in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage...with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical … more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a ... commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality... Clinical Practices (GCPs). The role partners with Clinical Development, Clinical Operations, Medical Affairs… more
- Merck & Co. (Rahway, NJ)
- …manufacturing to manage clinical development projects; and assist the Senior /Executive Clinical Director /Vice-President in ensuring that appropriate ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational ... study of marketed compounds. In executing these duties, theThe Senior Director may:Supervise the activities of Clinical Scientists in the execution of… 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 ... in one or several programs. Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …In addition, he or she will interact with the Companion Diagnostics Lead, Non- Clinical Research, Medical Affairs and other stakeholders to support the program. ... non- clinical research, translational biomarkers, companion diagnostics, bioinformatics, clinical development, medical affairs , regulatory etc.).Identify and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director , and Field Medical Affairs point to identify ... the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director...for select clinical trials, in collaboration with Clinical Director and Clinical Operations… more
- Merck & Co. (Rahway, NJ)
- …medicines. Our company's oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the ... monitoring, analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …products for aligned therapeutic / franchise area(s). Relationships Reports to the Senior Director of Value Communication and Contracting Strategy. Interacts ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution plans across and effective alignment within (eg with translational research, clinical operations, clinical development, medical affairs CSPV and ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Merck & Co. (North Wales, PA)
- Job DescriptionUnder the guidance of a Senior Director , within Outcomes Research (OR) the incumbent has the following responsibilities: Development of the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Merck & Co. (North Wales, PA)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director ... Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …products within responsible therapeutic / franchise area(s). Relationships Reports to Senior Director , Value Communication and Contracting Strategy. Interacts ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Merck & Co. (Rahway, NJ)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director ... Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... management or leading change management initiatives preferred- Prior experience in clinical development, Medical Affairs , or Global Marketing preferred-… more
