Senior Manager, GCP Quality Assurance
Pharmacyclics, Inc. - Sunnyvale, CA
At Pharmacyclics, Inc., we are pioneering a new era of patient-friendly oncology therapy through a target-based approach to medicine. With three molecules in the clinic (Phase II/III) & others soon to follow, our current pipeline of products shows vast potential to improve & prol...
Pharmacyclics, Inc. - Sunnyvale, CA
Designs, develops, evaluates & modifies computer programs to analyze & evaluate clinical data. Generate Study specific & ad-hoc clinical data listings, summary tables & figures....
Clinical Assay Development Scientist
Pharmacyclics, Inc. - Sunnyvale, CA
The Clinical Assay Development Scientist will initially develop & implement flow cytometry based PD assays for clinical specimens, & transfer these research processes & adapt into regulated environments suitable for future NDA filings. He/she will lead efforts into working with Q...
Pharmacyclics, Inc. - Sunnyvale, CA
Collaboration with clinical scientists on protocol design (author statistical methods section & generate study r&omization) Generate statistical analysis plan for assigned protocols (incl. Mock displays) Assume responsibility for individual studies, write statistical portion of i...
Pharmacyclics, Inc. - Sunnyvale, CA
Responsible for assuring compliance with SOP's & FDA regulations for the reporting of adverse events to regulatory agencies. Insures the uniform & timely processing of adverse event reports. Assists in the preparation of NDA Safety Updates, IND safety reports, investigator commun...