Executive Director, Clinical Data Acquisition

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

The Executive Director, Clinical Data Acquisition (CDA) is accountable for managing a team focused on the strategic and operational leadership of quality data collection activities across all clinical studies Phase I to IV. This includes, but is not limited to, the development and maintenance of policies, procedures, and data standards, maximizing usage of Electronic Data Capture (EDC) systems to ensure timely and high quality data collection, and proactive management of external vendors delivering clinical data using controlled, compliant, and secure methods. The Executive Director, CDA is accountable for the hiring, training, development, and management of employees within the departmental scope, to meet current and future business needs.

This incumbent must be capable of representing Clinical Data Management (CDM) and Data Science & Biometrics (DSB) in a leadership capacity. The role requires strong partnership and close collaboration with senior functional and matrix leaders across the R&D organization to ensure the successful, efficient, high quality, and compliant work delivery supporting the company portfolio.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Responsible for defining, and driving, the vision for optimized data collection that capitalizes on the latest technologies, is compliant with global regulatory requirements & guidances, and results in timely high quality clinical data generation.
• Ensure end-to-end management of all CDA activities including, but not limited to, company data standards, eCRF development, external data transfers/integration and reconciliation, and appropriately ensuring validation of clinical data systems and data repositories.
• Provide day-to-day leadership of the CDA team (employees, contractors, functional service providers) to instill a work ethic focused on proactive engagement and thought partnership with other roles in CDM and DSB, Information Technology, Strategic Sourcing & Procurement, Development Operations, Clinical Development, Global Patient Safety, and beyond.
• Maintain oversight of record retention strategies for clinical data and associated documentation in accordance with all applicable global regulations, company policies & procedures, and study-specific needs. This includes, but is not limited to, archival of clinical data at investigational sites, decommissioning of EDC systems, and contemporaneous storage of documentation in study-specific and/or system-specific document repositories (e.g. eTMF).
• At the study and portfolio level, proactively drive quality, efficiency, and innovation to ensure data collection deliverables are met within the established timelines, budget, and quality/compliance standards (e.g. providing input to protocol design, database design, and validation, and data management plans, including data review strategies and data quality assurance).
• Establish, and/or provide leadership in, governance structures working with relevant vendors including, but not limited to, data management vendor(s), sample management vendor(s), to ensure effective quality oversight of vendor deliverables and relationships supporting the company portfolio.
• Lead data standardization initiatives to ensure data collection methods comply with regulatory requirements, industry standards (e.g. CDISC), company policies & procedures, portfolio-level standards, and the practical needs of individual studies.
• Develop and implement a continuous process improvement strategy by monitoring key performance indicators, metrics, quality, and timeliness of study deliverables across the portfolio.
• Drives cross-functional senior leadership engagement to develop and deliver solutions for new service capabilities.
• Contribute to the development of departmental and study budgets, proactively managing budget, including accurate forecasting and cost accruals.
• Proactively identify and troubleshoot operational problems, issues, and obstacles, that help study teams to remove barriers to execution.
• Support study teams during submission, inspection, and other regulatory-related activities including, but not limited to, developing oversight processes, creating storyboards, presenting issues and mitigations.
• Strong customer focus and belief in Exelixis values; creating a positive value-based work environment for the CDA team. Able to lead, inspire and influence team/organization through rapidly changing business challenges.
• Stay current with regulatory and industry advances through cultivation of a wide external network. Able to represent Exelixis in data management, data strategy and other related capacities. Helps establish and maintain Exelixis CDM as an industry leader.
• May perform day-to-day tactical responsibilities to ensure successful execution of clinical studies across the company portfolio.

SUPERVISORY RESPONSIBILITIES:

• Directly and indirectly supervises employees.
• Responsible for the growth and development of all CDA employees.
• May indirectly supervise employee(s) through a dotted line structure.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in related discipline and a minimum of 18 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 16 years of related experience; or,
• PhD in related discipline and a minimum of 15 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience:

• Typically requires a minimum of 18 years of related experience and/or a combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry required.
• Experience in Oncology clinical trials is preferred.
• Experience leading major change initiatives is preferred.
• Demonstrated experience leading global data management and/or technical teams is required.
• Experience participating in regulatory submissions and inspections is required.
• A minimum of 12 years of line management experience is required.

Knowledge, Skills and Abilities:

• Has extensive experience in relevant industry/profession.
• Excellent understanding of clinical development, quality and regulatory standards (e.g.CDISC) and policies relevant to data management (e.g. GCP, ICH).
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Leads or manages the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs. May establish organizational policies in a major segment of the company.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Ability to identify, author, maintain and train staff on key data management SOPs and work-practice guidelines.
• Knowledge of Good Clinical Practices (GCP) is essential.
• Demonstrated success managing data management activities performed by external vendors.
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.
• Environment: primarily working indoors.

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.