/JOB PURPOSE The Associate Director, Product Management Cybersecurity Operations & Engineering designs, implements, manages, and improves secure technology solutions for the organization's information systems. The position is responsible for analyzing the organization's current cybersecurity infrastructure and identifying any weaknesses or vulnerabilities that must be addr

/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

Support the Director of Procurement within SS&P to establish clear vision, objectives & project plans for Procurement Systems and related integrations. Collaborate and help lead strategic thinking to identify and drive SS&P system and business process innovation and automation opportunities. Management and Administrator role for SAP ARIBA GB (Guided Buying) and SAP ARIBA

/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 Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on early phase (1/2) trials. Sets direction for statistical support of translational medicine and clinical biomarkers. Understands at a deep level clinica

/JOB PURPOSE The VP, Clinical Pharmacology builds and leads an experienced team of clinical pharmacologists with responsibilities to integrate clinical pharmacology strategies across pre clinical and clinical development, including drug approval and post approval activities. The incumbent has a strong understanding of pharmacokinetics, pharmacometrics, compartmental modeli

/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

/JOB PURPOSE The Senior Accountant is primarily responsible for financial reporting, maintaining the General Ledger, and supporting other functions within the accounting department. This position will play an active role in the financial close process and preparation of month end journal entries which includes various expense accruals, prepaids, and allocations. ESSENTIAL

/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

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 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