Senior Director, Clinical Operations Compliance Management (Biotechnology / Oncology)

SUMMARY / JOB PURPOSE (Basic purpose of the job) :

The Senior Director, Clinical Operations Compliance Management (COCM) is responsible for ensuring that clinical research activities are conducted by clinical staff in accordance with ICH GCP, relevant international and local regulations, requirements and guidelines, as well as Exelixis written standards. Key activities include focus on risk management, issue management, vendor oversight and site and data monitoring. COCM drives a common approach to study conduct, compliance, risk and issue management as well as management of protocol deviations. The Senior Director of COCM is a key partner with our Quality Assurance team and other functional groups (including Clinical Development, Data Management, etc.) and is responsible for 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. This Leader focuses on streamlining and standardizing cross-functional processes and templates as well as supporting development on the use of systems managed by the Clinical Operations function. The Senior Director of COCM utilizes data from internal sources and external initiatives to identify and highlight drivers of change and recommend process improvements.

ESSENTIAL DUTIES / RESPONSIBILITIES :

• Leadership of risk and issue management process for Clinical Operations focusing on compliant delivery of study execution.
• Provide trends and other relevant reporting to Process Owners and Clinical Operations and / or appropriate Leadership Teams and help translate trends to enable process improvements and smart risk-based decisions.
• Define strategy and methodology for functional risk / issue management, create annual functional risk management plan to ensure inspection readiness, review periodically the outcomes of risk management / management monitoring; 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.
• Provide development leadership 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 :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education :

Experience :

Knowledge, Skills and Abilities :

Work Environment / Physical Demands :

Our office is a modern, open-plan space that foster collaborations 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

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 $246,000 - $349,500 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.