New

Associate Clinical Operations Compliance Director

Exelixis
paid holidays, sick time, 401(k)
United States, California, Alameda
Mar 31, 2026
SUMMARY/JOB PURPOSE (Basic purpose of the job): The Associate Clinical Operations Compliance Director will support clinical research activities in accordance with ICH GCP, relevant international and local regulations, requirements and guidelines, as well as Exelixis written standards. Supports the focus on risk management, issue management, vendor oversight and site and data monitoring. The Associate Clinical Operations Compliance Director is a key partner with our Quality Assurance team and other functional groups (including Clinical Development, Data Management, etc.) and will assist in supporting inspection readiness activities, driving cross-study consistency in study execution and compliance with governing functional procedures and processes, and escalation of identified operational issues within development and of identified quality issues to QA. ESSENTIAL DUTIES/RESPONSIBILITIES: Support the risk and issue management process for Clinical Operations focusing on compliant delivery of study execution. Contribute to strategy and methodology for functional risk/issue management, assist in creating annual functional risk management plan to ensure inspection readiness; collaborate cross-functionally on risk management activities, and escalate to appropriate governance and adapt accordingly. Provide support to Clinical Operations (and other functions being supported by embedded compliance role) CAPA owners, including owner assignment, follow-up and completion. Assist with updates on CAPA completion data (late, near due, due later). Work closely with and act as liaison for Quality Assurance team and other functional teams across R&D and beyond. SUPERVISORY RESPONSIBILITIES: None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: Bachelor's degree in related discipline and a minimum of 11 years of related experience; or, Master's degree in related discipline and a minimum of 9 years of related experience; or, Doctoral degree in related discipline and a minimum of 5 years of related experience; or, Equivalent combination of education and experience. Experience: Experience in biotech/pharmaceutical industry required. Current understanding of the relevant external scientific, legal and regulatory environment. Knowledge, Skills and Abilities: Strong knowledge of biopharmaceutical industry regulations, standards and best practices. Must be a self-starter, quick learner, strong collaborator and team player with ability to work independently with minimal supervision. Must have excellent analytical, strategic thinking, problem-solving, time management, change management and organizational skills with demonstrated ability to work in a fast-paced environment and adapt to changing business plans and priorities. Strong interpersonal, verbal and written communication skills. Strong attention to detail. Ability to identify and communicate issues and risks. Excellent presentation skills. Ability to build and maintain strong relationships. Ability to influence without direct authority. Excellent computer skills, including advanced knowledge of Microsoft Excel, Word, PowerPoint and Outlook. Embraces Exelixis' core values: Be Exceptional; Excel for Patients; Exceed Together. Ensure processes are efficient and minimize burden on business owners across the clinical landscape. May include occasional travel (less than 10%) to current and/or prospective vendor facilities. Work Environment/Physical Demands: Our office is a modern, open-plan space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. #LI-EZ1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $168,500 - $238,500 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.