/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

/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 supporting Exelixis' small molecule development from early stage development through commercialization. This role is part of a team that leads the efforts at our contract manufacturing organizations (CMOs) to direct all aspects of our Drug Substance (DS) development and manufacturing. Specifically, s/he guides our CMO partners in p

The Senior Scientist II works in a fast paced environment with the Formulation development team, part of PSC department to drive a science based approach in formulation development and strategy for small molecule projects from First in Human (FIH) formulations to commercial formulation development. The Sr. Scientist II will actively engage with key stakeholders from Proce

Exelixis is dedicated to building a world class Structural Biology group to accelerate the discovery and development of novel therapeutics to fight cancer. We are seeking a highly skilled and motivated electron microscopist to supervise the installation and operation of a G4 CFEG Titan Krios electron microscope. The successful candidate will have extensive experience in c

/JOB PURPOSE The incumbent will be responsible for the day to day activities directed to support development and manufacturing of biological (antibody drug conjgates, mAbs, bispecifics) drug products (DP). The activities include formulation development, DP manufacturing process development, DP process technical ransfer, activities to support preparation and administration

/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 Associate Director provides technical leadership and support across multiple CMC biologics areas to drive downstream process development, technology transfer, and manufacturing of biological drug candidates with a focus on therapeutic proteins' purification process development. The Associate Director utilizes their technical expertise in downstream/purific

/JOB PURPOSE Responsible for the creation and maintenance of global Demand & Supply Plans for Exelixis commercialized products. This position works closely with Exelixis Partners as well as internal stakeholders to ensure the creation of optimized supply plans are aligned with inventory targets and ensuring continuous supply. They also work with key internal stakeholders t

/JOB PURPOSE As the Senior Director, Compensation, you will partner with team members to manage the development, implementation, optimization, maintenance, and communication of the company's compensation programs, processes, tools, and systems to ensure the achievement of equitable and competitive employee compensation in support of corporate objectives and in compliance w