About this opportunity
Exelixis, Inc. lists this Associate Clinical Operations Compliance Director (Biotechnology Oncology) opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
SUMMARY/JOB PURPOSE
The Associate Clinical Operations Compliance Director will support oncology 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 elevate 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. Will be responsible for one or more areas:
Training, Capability & Analytics – Build a standardized GCP and process training curriculum, drive ongoing capability and knowledge sharing and build and renew quality metrics to track progress and consistency across Clinical Operations.
BIMO & Inspection Readiness – Drive continuous inspection readiness across studies, keep TMF audit‑ready, run mock inspections and CAPA follow‑up and lead BIMO and health authority inspection response.
RBQM/RBM & Monitoring Oversight – Oversight of monitoring quality and CRO performance, risk‑based monitoring signals and timely escalation of site and data issues.
Performs other duties as assigned Complies with all policies and standards SUPERVISORY RESPONSIBILITIES None
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
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 Required: 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.
ENVIRONMENTAL REQUIREMENTS
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-JD1
SALARY AND BENEFITS
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $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.
401k plan with generous company contributions
Group medical coverage
Dental coverage
Vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Opportunity to purchase company stock
Long‑term incentives
15 accrued vacation days in first year
17 paid holidays including a company‑wide winter shutdown in December
Up to 10 sick days throughout the calendar year
Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales‑based incentive plan.
ACCOMMODATION CONTACT
If you have a disability and need an accommodation in relation to the recruiting process, please email us at:
WORKING CONDITIONS
Our office is a modern 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.
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. Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial. As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult‑to‑treat cancers, we’re seeking to add talented, dedicated employees to power our mission. Cancer is our cause. Make it yours, too.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.