/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 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 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 Associate Clinical Supplies Director designs, develops, and implements the clinical supplies strategy to ensure appropriate processes are established and clinical supplies deliverables are met for clinical trials. This individual also manages clinical supply activities including planning and forecasting of clinical supply, oversight of clinical packaging,

/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 This role provides CMC Regulatory expertise and leadership for commercial and development projects. This role recognizes the different requirements and restrictions for external data communication and presentation and represents the Regulatory considerations and point of view. This role also exercises strategic approaches for Health Authority filings and commu

/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 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 Strategic Supplier Relationships Director is responsible for optimizing partnerships within multiple areas; including (but not limited too) full service CRO providers, central and local laboratories, interactive response technology, pharmacovigilance and data management service providers. This individual is the key point of contact for Product Development

/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 This role is responsible for overseeing all aspects of drug safety study operational activities from study start up to close out. This individual oversees case workload distribution, responds to case questions, coordinates multiple drug safety projects and/or studies simultaneously, involving interaction with business partners, CRO's, and specialty pharmacies