- AbbVie (Irvine, CA)
- …health authority meetings. + Ensure adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications + Bachelors degree in the sciences; advanced degree (eg, MS, PhD, PharmD) preferred. + Ability to provide input and direction to clinical research with appropriate supervision. + At least 5 years of clinical… more
- BeOne Medicines (San Mateo, CA)
- …clinical development, program leadership, biometrics, clinical operations, safety/ pharmacovigilance , regulatory, molecular diagnostics, and translational research. ... **Key roles and Responsibilities:** + Key contributor in Clinical development strategy, planning and leading presentations to various internal governance committees + Provides leadership and clinical oversight across all assigned studies and programs (up to 2… more
- University of Maryland, Baltimore (Baltimore, MD)
- …science, including: Chemistry, Manufacturing, and Controls (CMC); Clinical Research; Pharmacovigilance ; Phase IV Research (eg, Pharmacoepidemiology); and Drug and ... Biologics Discovery. Additionally, responsibilities include a Certificate in regulatory science, which is the first two courses in the MS in Regulatory Science. The student population for the program possess a diverse range of backgrounds including regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …overall safety information for studies and products in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. + Makes decisions regarding study conduct related to scientific integrity. + **External Interactions** + Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders in… more
- Johns Hopkins University (Baltimore, MD)
- …focus on their translational value in drug discovery, clinical trials, pharmacovigilance , and regulatory science. Tissue-Engineered Systems for Drug Discovery and ... Development - 410.657 This course explores how engineered tissues and organotypic models are revolutionizing the drug development process. Students will learn about sca?old design for drug testing, 3D cultures, organoids, organ-on-chip technologies, and how… more
- Boehringer Ingelheim (Ridgefield, CT)
- …& Clinical Pharmacology, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance to implement discovery and development toxicology strategies that enable ... the progression of optimized drug candidates. + When appropriate, take lead to develop plan and lead sub-team for investigative studies to support investigations on mechanisms of toxicity. + Serve as NDS Therapeutic Area lead, and/or provide guidance and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. + Makes final decisions regarding study conduct related to scientific integrity. **External Interactions** + Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to… more