Senior 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 h