Sr. Director, Clinical Compliance

SUMMARY/JOB PURPOSE: The Senior Director, Clinical Compliance is responsible for the leadership of a Clinical Compliance team and ensures risk management, issue management, and management monitoring are implemented and embedded across the Development Organization. The leader of Clinical Compliance drives a common approach to quality, compliance, risk, and issue management. This role ensures 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. The Sr. Director of Clinical Compliance is a key partner with our Quality Assurance teams and other functional groups to optimize the best approach to Inspection readiness, oversight of quality performance metrics, and issue escalation of quality issues. This Leader focuses on streamlining and the standardization of Quality processes and templates and use of quality systems across lines. The Sr. Director of Clinical Compliance utilizes data from internal sources and external initiatives to identify and highlight drivers of change and recommend process improvements. This role is expected to lead, inspire, and develop a high-performing group of Clinical Compliance, Risk Management professionals. ESSENTIAL DUTIES AND RESPONSIBILITIES: The responsibilities include but are not limited to the following: Leadership of risk and issue management process for Development Operations focusing on Clinical Delivery Provide trends and other relevant reporting to Process Owners and Development Ops and/or appropriate Leadership Teams and help translate trends to enable smart risk taking and process improvement. Define strategy and methodology for functional risk/issue management; create annual risk management plan to ensure inspection readiness, review periodically the outcomes of risk management/ management monitoring; escalate to appropriate governance and adapt accordingly. Provide oversight of CAPAs to completion including ensuring all CAPAs have current, relevant owners assigned and engaged and that CAPA owners are clear on their accountabilities. Provide Development Operations LT with reports of CAPA completion data (late, near due, due later) Work closely and act as liaison for Quality Assurance team and other functions teams across development and beyond Lead a quality culture throughout Development Operations and build compliance capabilities within the Clinical Compliance and Risk Management team. SUPERVISORY RESPONSIBILITIES: Manages multiple direct reports. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor’s degree in related discipline and a minimum of 15 years of related experience; or, Master’s degree in related discipline and a minimum of 13 years of related experience; or, Doctoral degree in related discipline and a minimum of 12 years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Typically requires a minimum of 15 years of related experience and/or combination of education/training and experience. Experience in biotech/pharmaceutical industry required. Experience in biotech/pharmaceutical industry: CROs, R&D outsourcing, purchasing or procurement roles required. Minimum Level Of Job-Related Experience is Required: Evidence of leadership and management skills of a team at a senior level in a relevant industry role involving strong engagement with external suppliers. Current understanding of the relevant external scientific, legal, and regulatory environment. Prior experience leading a team This role requires highly developed capabilities in the following areas: Leadership and networking skills Communication and engagement skills Partnership and collaboration skills Influencing skills to drive robust oversight processes across a complex supplier landscape Knowledge/Skills: In-depth knowledge of biopharmaceutical industry regulations, standards and best practices. Poise and confidence to provide verbal and written communications and formal presentations to Exelixis’ and external vendors’ executives, senior management, functional management and individual contributors. 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. JOB COMPLEXITY: Accountable for leading, designing, and driving changes in ways of working across a complex network of stakeholders and SMEs. Ensure processes are efficient and minimize burden on business owners across the clinical landscape. Responsible for embedding a risk and issue management framework. WORKING CONDITIONS: May include occasional travel (less than 10%) to current and/or prospective vendor facilities. #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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $217,500 - $307,750 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. 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.

Salary : $217,500 - $307,750