Exec Medical Director, Pharmacovigilance Risk Management (PVRM) Exelixis IncExec Medical Director, Pharmacovigilance Risk Management (PVRM)Alameda, CA$355,000–$504,000 / yearSUMMARY/JOB PURPOSE: The Executive Medical Director, PVRM is responsible for the development and execution of the global product safety strategy for complex clinical development program(s) as well as post-marketing pharmacovigilance activities for Exelixis products. Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
Senior Clinical Research Associate FSP - Dallas TX, San Francisco CA, or Jacksonville FL Parexel International CorpSenior Clinical Research Associate FSP - Dallas TX, San Francisco CA, or Jacksonville FLSan Francisco, CAThis position focuses on all activities required to evaluate, initiate, monitor, and close clinical sites in compliance with the Code of Federal Regulations (CFR) and International Council for Harmonization/Good Clinical Practice (ICH/GCP) Guidelines. Works proactively with sites to address site issues and action items to obtain swift resolution and/or escalate to protocol lead/principal investigator (PL/PI) per CMP.
NewSenior Vice President, Clinical Development / Chief Medical Officer ImmunEdge, IncSenior Vice President, Clinical Development / Chief Medical OfficerRedwood City, CAFull timeThe individual will partner closely with Research, Translational Medicine, Clinical Operations, Regulatory Affairs, Biometrics, Pharmacovigilance, CMC, and executive leadership to establish development priorities and advance programs efficiently and rigorously. The successful candidate will bring deep expertise in oncology and immune-oncology drug development, a strong understanding of translational science and biomarker driven development and demonstrated experience advancing novel therapeutics through clinical development and regulatory interactions.
Clinical Project Assistant Thorough GroupClinical Project AssistantSan Francisco, CaliforniaThe Clinical Project Assistant will play an important role in keeping study activities organized and on track, maintaining high-quality clinical documentation, supporting the Trial Master File, coordinating study meetings and communications, and assisting with the day-to-day operational needs of the clinical program. As the organization continues to advance its clinical development activities, they are seeking an experienced and highly organized Clinical Project Assistant (CPA) to provide operational and administrative support to Clinical Operations and the broader clinical study team.