Exelixis - Alameda, CA
SUMMARY/JOB PURPOSE: In collaboration with clinical and project teams of the company, the Clinical Science Director.... Collaborates with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms...
May 26
Pharmacovigilance Risk Management Medical Director (PVRM)
Exelixis - Alameda, CA
project(s). The role collaborates closely with Drug Safety Operations staff (on medical aspects of ICSRs) and Clinical...SUMMARY/JOB PURPOSE: The PVRM Medical Director is responsible for the medical review of Individual Case Safety...
April 20
Exelixis - Alameda, CA
such as data management, clinical operations, clinical science, regulatory affairs, and drug safety. Project management... statisticians. Has led phase 1 and phase 2 oncology studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development...
May 1
Assoc Drug Substance Manufacturing Director
Exelixis - Alameda, CA - $159,000-225,500 per year
organizations (CMOs) to direct all aspects of our Drug Substance (DS) development and manufacturing. Specifically, s/he guides.... Review and approve batch documents for drug substance manufacturing ensuring they meet the technical and regulatory...
April 26
Sr. Clinical Development Medical Director
Exelixis - Alameda, CA
. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Monitors adherence to protocols... for company sponsored trials. Support project teams with therapeutic area specific information. Collaborate with internal safety...
May 4