/JOB PURPOSE The Associate Regulatory Operations Director is responsible for overseeing submission activity for the company's submission portfolio, with first line accountability for managing the submission forecast and ensuring proper staffing for upcoming submissions. She/he utilizes in depth knowledge of global regulatory submission requirements and works collaborativel

/JOB PURPOSE The Clinical Operations Associate Director combines end to end design, execution, and reporting of clinical trials with leadership in study teams and across matrix teams. This position is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protoco

/JOB PURPOSE The Vice President, Pharmacovigilance provides strategic leadership, management and oversight of case management, operational processes, the quality management system, compliance operations and monitoring; and safety systems for the Exelixis Drug Safety Department and its partners. In addition, this role oversees the case management and related operational act

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

/JOB PURPOSE Responsible for assisting in the development, implementation and maintenance of QA systems and activities supporting GCP and PV operations. Provides assistance with planning and conducting audits of vendors and associated documentation activities. Essential Duties And Responsibilities Responsible for assisting in the development of internal processes and syste

/JOB PURPOSE In collaboration with clinical and project teams of the company, the Clinical Science Director designs, plans and develops studies in early and/or late phase clinical oncology. Prepares and authors clinical development related documents including study synopses and protocols. Summarizes study results for preparation of documents and publications. Supports proj

/JOB PURPOSE The PVRM Medical Director is responsible for the medical review of Individual Case Safety Reports (ICSRs) for Exelixis products and is involved with other safety deliverables (eg safety surveillance) for assigned project(s). The role collaborates closely with Drug Safety Operations staff (on medical aspects of ICSRs) and Clinical Development (medical ICSR disc

/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 t

/JOB PURPOSE Ensures risk management, issue management, and risk/issue monitoring are implemented and embedded across their responsible trial portfolio and functional areas of focus. Ensures clinical research activities are conducted by clinical staff in accordance with ICH GCP, relevant international and local regulations, requirements, and guidelines. Partners with quali

/JOB PURPOSE Support the early stage pipeline by working across the Medical Affairs sub functions, including the Medical Communications, Medical Information, Medical Science Liaison, and Operations teams. This position also work with several cross functional stakeholders outside of Medical Affairs. Essential Duties And Responsibilities Provide timely information and strate

/JOB PURPOSE The Clinical Operations Associate Director combines end to end design, execution, and reporting of clinical trials with leadership in study teams and across matrix teams. This position is accountable for planning and leading the delivery of studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study protoco

/JOB PURPOSE In collaboration with the Exelixis clinical teams, the primary role is to lead and execute early/late stage clinical trials for oncology products in development. Participates in the design/planning of clinical studies and helps with the interpretation of study results. Establishes and approves scientific methods for design and implementation of clinical protoc

/JOB PURPOSE Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company wide initiatives around end to end labeling and provides dedicated support on Regulatory related activities and deliverables. This role requires an e

/JOB PURPOSE The Associate Corporate Counsel, Contracts will provide transactional legal support to the Pharmaceutical Operations & Supply Chain client group (PSC), and other departments within the Research & Development division, in collaboration with cross functional business teams and with support from senior members of the Legal team. Please note this is an onsite role

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval, with a particular focus on biologics (ADCs, bispecifics, and etc.). Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines, as well as companion diagnostics, as appropriate. Provide