- Teva Pharmaceuticals (Parsippany, NJ)
- …Procedures + Resolves safety or relevant clinical issues in consultation with Global Drug Safety and Pharmacovigilance, SVP Late Clinical Development and ... Senior Director Clinical Development - Respiratory Date:...the cross-functional clinical development team + Supports Global Clinical Operations in clinical … more
- Merck (Rahway, NJ)
- …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 (Rahway, NJ)
- …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
- Teva Pharmaceuticals (Parsippany, NJ)
- …internal expert in all aspects of regulatory medical writing, T&D, and clinical drug development + Knowledge of global regulations and guidelines for T&D and ... Sr Director , Global Regulatory Medical Writing &...extensive accountability, strategic vision, and planning direction at the global function level for clinical regulatory documents.… more
- Merck (Rahway, NJ)
- **Job Description** The Global Clinical Supply organization is accountable for managing the 'end-to-end' integrated clinical supply chain across the full ... company Research Laboratories portfolio of clinical trials. Global Clinical Supply...the timelines for bulk manufacturing needs and release of drug product across assigned program(s). + Works directly in… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Considered an internal expert in all aspects of regulatory medical writing and clinical drug development. Influences and potentially leads creation of regulatory ... Director , Therapy Area Head, Global Regulatory...in the strategic planning, scope determination, and development of clinical and regulatory documents used in drug … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …success as a project manager/leader in planning and executing strategies for global drug development, commercialization and life cycle management. preferred + ... **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. (Basking Ridge, NJ)
- …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
- Gilead Sciences, Inc. (Parsippany, NJ)
- …help create possible, together. **Job Description** We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology ... SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of… more
- System One (Basking Ridge, NJ)
- Director Clinical Safety 12 month contract...role may function as a key member of the Global Product Team in collaboration with Clinical ... $100- $120 (dependent on experience) Fully remote Description: The Director , Clinical Safety, will be a product...Global Product Team or specific sub-teams such as clinical study team and submission team, providing the safety… more
- Pfizer (New York, NY)
- The Associate Director , Clinical Diagnostics will support development of Diagnostics and Global Diagnostic Strategies across therapeutic areas. We are ... identify and implement diagnostic strategies to enable and support the global development and commercialization of differentiated therapies. The successful candidate… more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... preferred + Minimum of 8 years total pharmaceutical/related industry experience in drug development required + Demonstrated knowledge of global regulatory… more
- J&J Family of Companies (Raritan, NJ)
- Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Leader. This position can be located in Spring House, PA; Horsham, PA; ... people can reach their potential. At Johnson & Johnson, we all belong. The Director , Global Regulatory Leader, is responsible for global regulatory… more
- Merck (Rahway, NJ)
- …degree (eg, MS, MBA, Ph.D., PharmD) preferred + Experience and knowledge of clinical drug development strongly preferred; including the different phases of ... drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in...our company. ** ** **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Bristol Myers Squibb (Summit, NJ)
- …better place than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality oversight to Contract ... Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition to support the clinical and commercial release of Drug Product. This role will also… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and participates in the creation and updating of processes and procedures in drug development management via the Global Development Functional Committee - PM ... pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines… more
- Merck (Rahway, NJ)
- …regulatory expectations and shape, present and defend regulatory documents and submissions. The Director is a skilled quantitative drug developer, with a strong, ... aligned, quantitative and model-informed framework to impact strategies and decisions of drug development teams. Finally, the Director mentors or supervises… more