- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- Drive Labeling Strategy, in-line with overall global regulatory strategy, by providing labeling expertise for Company Core Data Sheet (CCDS), USPI and local labeling ... labeling - understanding precedents & opportunities. + Ability to assimilate key clinical , scientific, and medical information and present it in a concise manner.… more
- BeOne Medicines (Pennington, NJ)
- …This role in the Manufacturing Science and Technology (MST) department supports BeOne's Drug Product Manufacturing site in New Jersey (Hopewell). This role will lead ... the site drug product MST function to support technology transfer, validation,...is responsible for managing the technical operations supporting both clinical and commercial manufacturing activities. **Essential Functions:** + Serve… more
- Parexel (Trenton, NJ)
- …we are expanding our esteemed Medical Sciences Team and seeking an Associate/Medical Director to support the growth of our Global Immunology and Inflammation ... needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate)...team, preferred, but not essential * A background in clinical aspects of drug development, including all… more
- Ascendis Pharma (Princeton, NJ)
- …including Commercial, Legal, Regulatory, Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...of Patients, Science, and Passion, we use our TransCon(R) drug development platform to fulfill our mission of developing… more
- Sanofi Group (Morristown, NJ)
- …The Development Scientific Director (DSD) is a responsible member of the clinical team dedicated to the development and execution of clinical strategies and ... compound program. The primary purpose of the development scientific director 's position is to support the Clinical ...+ A minimum of 3 years of phase I-III clinical trial/ drug development experience within the ophthalmology/retina… more
- Organon & Co. (Jersey City, NJ)
- …development and biopharmaceutics, and clinical pharmacology a discipline to facilitate clinical development of drug candidates. + Working knowledge of early ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of … more
- Bristol Myers Squibb (Princeton, NJ)
- …The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, focusing on early-stage development ... member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug -diagnostic strategies and health… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), Data ... on the early development CNS portfolio and Early Development Teams. This Senior Director is a strategic scientific and clinical leader accountable for the… more
- Sanofi Group (Morristown, NJ)
- …problem scoping and planning. + Good knowledge of industry best practices, global regulatory, processes, standards of drug development. **Demonstrate the ... classic translational and population PK modeling, PK/PD modeling, exposure-response modeling, clinical trial simulation, drug -disease modeling, PBPK modeling, to… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …, Medical Communications Lead, CNS Lead, and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory, Commercial). ... The Associate Director , Scientific Communications manages the execution of the...of Core Content **Cross-Functional Collaboration** + Partner closely with Clinical Development, Global Integrated Evidence & Innovation,… more