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:

• May manage direct reports and/or consultants.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• 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:

• 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.
• 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.

Knowledge, Skills and Abilities:

• Leadership and networking skills.
• Communication and engagement skills.
• Partnership and collaboration skills.
• Influencing skills to drive robust oversight processes across a complex supplier landscape.
• 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.
• 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.
• 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 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.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

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.