Associate Clinical Compliance Operations Director

SUMMARY/JOB PURPOSE:

The Associate Clinical Compliance Director ensures risk management, issue management, and risk/issue monitoring are implemented and embedded across their responsible trial portfolio and functional areas of focus.  Ensures clinical research activities are conducted by clinical staff in accordance with ICH GCP, relevant international and local regulations, requirements, and guidelines.  Partners with quality assurance (QA) teams and other functional groups across PDMA to execute inspection readiness, risk management, oversight of quality performance metrics, and issue escalation of quality issues.  The Associate Director provides Good Clinical Practice (GCP) guidance and best-practice expertise to facilitate optimal clinical trial execution compliance management as it relates to Process Deviations and CAPA management to and ensure study adherence to applicable GCP regulations throughout all phases of clinical development.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• As part of Clinical Compliance and Risk Management (CCRM) Team, represent Development Operations and collaborate with Quality Assurance on compliance-related activities, processes and functions
• Support Development Operations functions and Clinical Study Delivery Teams to maintain readiness, prepare for, and participate in regulatory agency inspections and Quality audits
• Create and manage the training curriculum for the Development Operations Organization, so every active employee is fully trained on GCP/ICH guidance and regulations through hands-on training and SOP/WI implementation
• Display active leadership as it relates to Development Operations management of process deviations, audit and inspection findings, and CAPAs
• Manage and track Development Operations internal and external audit responses. Support input and the review of investigator, vendor, process and system audits to ensure responses are complete and provided in a timely manner
• Manage and track Development Operations and Vendor assigned CAPAs validation, processing and resolution to ensure on time closure. Translate and facilitate with functional area partners an outcome to defined process, study plans or training updates
• Ensure inspection readiness, review periodically the outcomes of risk management/ management monitoring; escalate to appropriate governance and adapt accordingly
• Collaborate with cross functional teams to identify compliance program risks and mitigation strategies
• Establish and maintain CCRM key performance indicators, and metrics tools that interfaces with Quality Assurance representing the state of compliance for Development Operations
• Create and lead CCRM initiatives and infrastructure that drive compliance
• Collaborate with CCRM team members to ensure achievement of corporate and department goals 

SUPERVISORY RESPONSIBILITIES:

• None

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of 11 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 9 years of related experience; or,
• PhD in related discipline and a minimum of 5 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Typically requires a minimum of 12 years of related experience or the equivalent combination of experience and education/training.
• Typically requires a minimum of 10 years of pharmaceutical/biotechnology/CRO in quality management of clinical trials, training, clinical operations, project management.
• Advanced knowledge of ICH-GCP guidelines and applicable drug development regulations.
• Experienced in leading inspection readiness activities.
• Experienced in leading the development of SOPs and other process related documentation.
• Experienced in supporting clinical trial GCP compliance/quality management activities.
• Strong understanding of drug development and clinical trial execution, including other required functional areas involved in clinical trials.
• Strong working knowledge of  Clinical Risk Management and Mitigation strategies.
• Experienced in training GxP curriculums in a large setting.

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 l