- Bayer (Whippany, NJ)
- …minds to make a real difference, there's only one choice.** **Sr Director, Global Clinical Lead , Diagnostic Molecular Imaging** The Senior Director, Global ... Phase 1 to Phase 3, with an emphasis on late -phase development . You will focus on the...RESPONSIBILITIES** The primary responsibilities of this role, Senior Director, Global Clinical Lead Diagnostic Molecular Imaging, are… more
- Sanofi Group (Morristown, NJ)
- …timelines; ensures appropriate communication, resolution and/or escalation as needed + Lead global filing and lifecycle management activities for device ... **Job title** : Global Regulatory Affairs Device Lead (Associate...product lifecycle. Our department bridges the gap between technical development , manufacturing operations, and global regulatory authorities… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …leading to NDA, BLA, and/or Global filings. **Key Job Responsibilities** + Lead the clinical development strategy and execution for assigned programs after ... Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in...compliance with GCP, regulatory requirements, and internal processes. + Lead and contribute to development of clinical… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …+ Develop and implement global CMC regulatory strategies for late -stage development , marketing applications (eg, NDA/MAA), and post-approval lifecycle ... to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development , Quality, Manufacturing, Global Regulatory… more
- Bristol Myers Squibb (Princeton, NJ)
- …. The Clinical Development Lead sits within Clinical Development , which is a global organization dedicated to the effective design ... a given Target Product Profile (TPP) + Collaborates with Global Development Operations/ Global Compliance Group...assure a seamless transition into late stage development (Phase II-III trials) + Ability to lead… more
- Bristol Myers Squibb (Madison, NJ)
- …**Position Summary** The Clinical Development Program Leader sits within Clinical Development , which is a global organization dedicated to the effective ... portfolio view + Provide strategic insights into the clinical development plans + Lead search and evaluation...concept trials and will assure a seamless transition into late stage development (Phase II-III trials.) **Governance… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Business Development & Licensing - Deal Lead will be responsible for identifying, ... pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. Tanabe Pharma Corporation has discovered and produced several… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …planning, global preferred + Proven success leading cross-functional teams through late -stage development and global commercialization + Expertise in ... impact patients worldwide with autoimmune and rare diseases. **Responsibilities:** + ** Global Launch Leadership & Market Preparation:** Lead cross-functional … more
- Bristol Myers Squibb (Princeton, NJ)
- …industry + Demonstrated ability to lead a cross-functional team to execute Development Plans which have a global perspective and focus on product ... Portfolio Management, global regulatory & safety, and global development operations), and other functions (including...including education where applicable + Expertise in the drug development process, especially late development … more
- Bristol Myers Squibb (Madison, NJ)
- …across the organization, including medical safety assessment, clinical development , global regulatory, epidemiology and others. The SBRA Lead will drive ... Benefit-Risk Project Team (BRPT) in structured benefit-risk assessment of products. + Lead development of Core SBRA document and facilitate effective.… more