- Genmab (Plainsboro, NJ)
- …and authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director , Global Clinical Drug Supply to be part of ... at the forefront of bringing medicines to cancer patients and other serious diseases. Director , Global Clinical Drug Supply will work in partnership with… more
- Genmab (Plainsboro, NJ)
- …collaboration, excellence, and a can-do attitude to achieve results.You will be reporting to Director , Global Clinical Drug Supply in Copenhagen, ... an experienced Senior Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team.As Senior Clinical Drug Supply… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery ... of a single or multiple clinical trials from strategy outline through to CSR by...CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible ... Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be...global regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as a project manager/leader in planning and executing strategies for global drug development, commercialization and life cycle management. preferredProven ... Summary This position is responsible for providing project management, drug development expertise to Global Project Teams...these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... make decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup.This position requires strong organization and… more
- Genmab (Plainsboro, NJ)
- …needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development, Regulatory, and other cross ... disease area expert in both internal and external venues including the US/ Global cross-functional teams, clinical development teams, advisory boards, steering… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and ... Director , Clinical Development Join a Legacy...diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Genmab (Plainsboro, NJ)
- …for new trials to ensure efficient and effective trial operations.Point of Contact for Global Clinical Trial Managers: Act as the primary point of contact, ... essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in...a pivotal role in managing the relationships with the clinical vendors as well as coordinate and manage outsourcing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development projects. Represents Daiichi Sankyo's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex clinical and clinical pharmacology documents (eg, pivotal ... advise study teams regarding regulatory requirements and ICH guidance for clinical documentsParticipate in initiatives within the Global Regulatory Writing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …document. May participate in meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development: Primarily participates ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck (Upper Gwynedd, PA)
- …medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle of ... decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication;...study of marketed compounds. In executing these duties, the Director may: Supervise the activities of Clinical … more
- Merck (North Wales, PA)
- …with a particular focus on obesity and obesity-related metabolic disorders. The Senior Director will manage the entire cycle of clinical development, including ... placement, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior Director may be responsible for** + Evaluating pre- clinical … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Sciences, Hematology, leads in the...(TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical ... early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical Director (s) (MDs)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- … Director , Clinical Study Startup to establish the strategy driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and make decisions where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This position requires strong organization and… more
- Actalent (Basking Ridge, NJ)
- Job Title: Director , Clinical SafetyJob Description The Director , Clinical Safety will be responsible for leading overall product safety strategy, safety ... for compound/product safety, including project-specific training and coaching. + Represent the Clinical Safety and Pharmacovigilance (CSPV) on the Global Product… more
- Merck (West Point, PA)
- …Our company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development ... **Job Description** Our company is a global health care leader with a diversified portfolio...The Director will report to the Executive Director of Vaccine Drug Product Development, have… more
