/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 Sr Manager 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 Sr Manager utilizes their technical expertise in downstream/purification process de

/JOB PURPOSE The Scientist IV, Biologics Upstream Process Development will independently conduct laboratory experiments with limited supervision to develop cell culture processes and support technology transfer and manufacturing of biological drug candidates. The incumbent will utilize their technical expertise in upstream/cell culture process development of biologics (the

/JOB PURPOSE The Senior Staff Engineer, Product Management Business Applications will ensure high quality Drug Development Business Applications support. The role will lead the delivery of Support, DevOps, and initiatives in Global Patient Safety (GPS) functions from a Drug Development perspective. Implements right fit product and execution by collaborating with cross func

/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 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

/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

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

/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