Director, eClinical Solutions

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

Oversees, develops and manages clinical and operational data systems and infrastructure-related projects while collaborating and coordinating with all other functions across Data & Statistical Sciences (DSS), Clinical Operations, IT, and other stakeholders/departments. Oversees the evaluation and implementation of data capture systems (e.g., Electronic Data Capture (EDC)) in support of clinical trial execution, along with necessary integrations with other systems.

Key member of the Clinical Data Management department with accountability for technology solutions and processes to support all clinical trials Phase I to IV with a combination of employees or Functional Service Provider (FSP) staff.

ESSENTIAL DUTIES/RESPONSIBILITIES:

• Works closely with the broader Clinical Data Management team to understand strategy and business needs as well as industry trends and evolving EDC technology in the marketplace.
• Provide Business Ownership of EDC systems, evaluate and select EDC vendors and associated service providers. Establish governance and oversight and governance of these vendors.
• Evaluate the optimal use of data capture technologies to ensure efficient and effective clinical trial execution. Partner with stakeholders to develop strategies that transform the use of technologies in Clinical Data Management that enhance the deployment of human resources to optimally productive and value-added tasks vs tasks that would be better automated through the use of AI, ML, etc.
• Support the development and governance of Data Standards as well as the creation of standard eCRFs to streamline processes.
• Foster a leadership culture which attracts, develops and retains high caliber individuals with expertise in clinical technology capable of and committed to providing valuable and creative input to Exelixis projects to achieve or exceed company goals. Ensure accountable performance management of all staff against personal management plans and expected behavior.
• Lead Continuous Process Improvement initiatives to implement clinical and operational data strategies.
• Manage time and resource constraints across multiple projects.
• Contribute to the development and implementation of new or improved processes for Clinical Data Management.
• Provide oversight on quality and timeliness of task completion by direct reports.
• Develop and implement training curriculum for data management activities and principles as required.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises employees.
• May indirectly supervise employee(s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in related discipline and a minimum of 13 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 11 years of related experience; or,
• PhD in related discipline and a minimum of 8 years of related experience; or,
• Equivalent combination of education and experience.
• May require certification in assigned area.

Experience:

• Typically requires a minimum of 15 years of related experience and/or 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 required.
• Experience participating in regulatory submissions and inspections is required.
• A minimum of 8 years of line management experience is preferred.
• Extensive people leadership experience including talent development and performance management.
• Excellent understanding of clinical development, quality and regulatory standards (eg., CDISC) and policies relevant to Clinical Data Management and risk-based data management approach of clinical data (e.g., GCP, ICH).

Knowledge, Skills and Abilities:

• Has extensive experience in relevant industry/profession.
• 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.

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