Associate Clinical Programming Director

Role Summary

Associate Clinical Programming Director. This role guides strategic direction and priorities of the function, partnering with the Research & Development organization. It develops outputs and listings to support Data Management and Clinical Operations in reviewing data issues and ensures on-time delivery of pivotal initiatives across the organization.

Responsibilities

• Prepare/update specifications per the Data Manager/Clinical Operations requirement to identify data issues.
• Create Clinical programming reports such as EDC listings, Edit check reports, Coding review reports on AEs and concomitant medication data, Data review listings, Patient profiles, Lab/vendor and Serious AE reconciliations, Special character listings, protocol deviation listings, Patient Narratives, and CRF metric reports.
• Communicate with the Data Manager and Clinical Operations lead on data issues.
• Develop standard macros and utilities to reduce repeated tasks or to implement automation.
• Build strong relationships with partners, influence and collaborate across PDMA and Research organizations.
• Balance internal and external expertise to secure the right people at the right time to support the development of the Exelixis pipeline.
• Provide strategic leadership in developing and maintaining data delivery models/options, balancing customer needs and efficiency, and serving as an interface for internal or external partners.
• Drive global standardization, continuous improvement, and productivity gains.
• Drive innovation to update and deliver new capabilities, including capability builds and rollout.
• Develop, coach, mentor, motivate, and inspire individuals within the organization and attract, recruit, and retain top talent.
• Strategic workforce planning and capability building for current and emerging needs within CP.
• Lead or participate in critical initiatives as needed, partnering with functional leaders to ensure high-quality contributions and readiness for implementation. Initiatives should significantly impact Clinical Operations, TA, or R&D.
• Participate in industry forums to drive and shape future ways of working.
• Deliver agreed departmental activities within the budgeted target.
• Ensure compliance with ethics, policies, and standard procedures.

Qualifications

• Bachelor’s degree in Biological Sciences, Data-related field (e.g., Computer Science, Biology, life science) or equivalent with a minimum of 11 years related experience; or
• Master’s degree in Biological Sciences, Data-related field or equivalent with a minimum of 9 years related experience; or
• Equivalent combination of education and experience.

Knowledge, Skills And Abilities

• Strong technical expertise in SAS, R, Python, Spotfire, and Tableau.
• Experience leading data acquisition, analytics, and AI-based capabilities across multiple Clinical domains.
• Experience implementing business processes and managing functional budgets.
• Problem-solving ability to resolve conflict and handle complex problems independently and with others.
• Innovative mindset with ability to influence and inspire change.
• Analytical skills, conceptual thinking, and vision to drive customer needs, performance, and risk management.
• Ability to explain technical concepts to non-technical stakeholders.
• Knowledge of the clinical development process, industry standards, and resources needed to manage trials of differing complexities.
• Ability to influence stakeholders and global teams.
• Proven experience leading global teams and working with external partners at senior levels.
• Ability to lead change positively and view it as an opportunity to improve performance.
• Experience in global line management, development, and mentorship of others.
• Ability to set and manage priorities, resources, and project initiatives in a global environment.

Work Environment/Physical Demands

• Environment: primarily working indoors on a computer in an office setting.
• Travel up to 10%