Tag: Exelixis

  • Job Vacancy Director, Project Management Exelixis

    Job title: Director, Project Management Company: Exelixis Job description: SUMMARY/JOB PURPOSE: The Director, Project Management partnerswith cross-functional project teams to develop and maintain project plans,Gantts/timelines, status reports, strategic development and filing plans.Oversees and manages the operational aspects of ongoing oncology drugdevelopment projects (IND-enabling, Phase 1 to 3, NDA/BLA filing submissions) andserves as liaison between project […]

  • Job Vacancy Clinical Trials Manager Exelixis

    Job title: Clinical Trials Manager Company: Exelixis Job description: SUMMARY/JOB PURPOSE: Coordinates the activities associated with the evaluation, initiation and management of clinical trials. Manages clinical studies, including CRO oversight. Coordinates the training of staff involved in trial management. ESSENTIAL DUTIES AND RESPONSIBILITIES: Manages clinical trials, including those conducted through Contract Research Organizations May hold […]

  • Job Vacancy Senior R&D Strategic Outsourcing Manager II (Category Manager, Investigator Support Services) Exelixis

    Job title: Senior R&D Strategic Outsourcing Manager II (Category Manager, Investigator Support Services) Company: Exelixis Job description: SUMMARY/JOB PURPOSE: The Senior R&D Strategic Outsourcing Manager II is a Category Manager within the Medical Affairs, Regulatory Affairs, Quality Assurance, & Drug Safety Services category and resides in the department’s Category Management & Leadership function. This individual […]

  • Job Vacancy Senior MRC Project Manager Exelixis

    Job title: Senior MRC Project Manager Company: Exelixis Job description: SUMMARY/JOB PURPOSE: The Senior Medical Review Committee (MRC) Project Manager partners with the GU Portfolio Management in strategic alignment and execution of critical interactions with HCP. Coordinates MRC meetings for discussion and approval of Scientific Exchange Materials to be used with HCPs in alignment with […]

  • Job Vacancy Senior R&D Strategic Outsourcing Manager II (Category Manager, Medical Affairs, Regulatory Affairs, Quality Assurance, & Drug Safety Services) Exelixis

    Job title: Senior R&D Strategic Outsourcing Manager II (Category Manager, Medical Affairs, Regulatory Affairs, Quality Assurance, & Drug Safety Services) Company: Exelixis Job description: SUMMARY/JOB PURPOSE: The Senior R&D Strategic Outsourcing Manager II is a Category Manager within the Medical Affairs, Regulatory Affairs, Quality Assurance, & Drug Safety Services category and resides in the department’s […]

  • Job Vacancy Senior Regulatory Affairs Manager Exelixis

    Job title: Senior Regulatory Affairs Manager Company: Exelixis Job description: SUMMARY/JOB PURPOSE: Manages US investigational new drug applications (IND), ex-US clinical trial applications, and related correspondence from the US Food and Drug Administration (FDA) and other regulatory authorities ESSENTIAL DUTIES AND RESPONSIBILITIES: Manages the preparation, submission and maintenance of US Regulatory applications, including routine amendments, […]

  • Job Vacancy Commercial Regulatory Affairs Senior Director Exelixis

    Job title: Commercial Regulatory Affairs Senior Director Company: Exelixis Job description: SUMMARY/JOB PURPOSE: Responsible for primary regulatory review of promotional materials. Provides regulatory strategic and operational leadership in the areas of advertising and promotion. This role demonstrates proficiency in understanding and interpreting clinical trial data to support Regulatory and cross-functional activities for Exelixis compounds. This […]

  • Job Vacancy Regulatory Affairs Associate Exelixis

    Job title: Regulatory Affairs Associate Company: Exelixis Job description: SUMMARY/JOB PURPOSE: Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. ESSENTIAL DUTIES AND RESPONSIBILITIES: Review clinical site regulatory documents to […]

  • Job Vacancy Senior Scientist II (Pharmacology, PK Modeler – Drug Discovery Sciences) Exelixis

    Job title: Senior Scientist II (Pharmacology, PK Modeler – Drug Discovery Sciences) Company: Exelixis Job description: SUMMARY: The major function of this position is to provide scientific input and support for pre-clinical PK, PD and TK studies to enable small molecule cancer drug discovery and development candidate selection. The candidate should have a strong working […]