Director, Clinical Programming

SUMMARY/JOB PURPOSE:

As a member of the Digital Strategy, Analytics, and Programming Leadership Team, this role guides and influences the strategic direction and priorities of the function and partners closely with the Research & Development organization, which is directly supported. The Director of Clinical Programming develops outputs and listings that support the Data Management and Clinical Operations teams in reviewing and addressing data issues.

The Director of CP sponsors and ensures the on-time delivery of pivotal initiatives that involve significant business, technical, and process improvements across the organization.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Prepare/update specifications per the Data Manager/ Clinical Operations requirements to identify data issues.
• Knowledge and experience in creating 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 effectively across PDMA and Research organizations.
• Balance internal and external expertise to secure the availability of the right people at the right time to support the development of the Exelixis pipeline.
• Strategic leadership in developing and maintaining data delivery models/options, balancing customer needs and efficiency, and being an interface for internal or external partners.
• Drive an environment of 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 & 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 across the business to ensure high-quality contributions and readiness for implementation. The initiative's scope should significantly impact the Clinical Operations organization, 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.

SUPERVISORY RESPONSIBILITIES:

• Oversees the daily operations of assigned staff.
• Supervises staff, including hiring, scheduling, and assigning work, reviewing performance, and  recommends salary increases, promotions, transfers, demotions, or terminations.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• Bachelor's Degree in Biological Sciences, Data in a related field (e.g., Computer Science, Biology, life science) or equivalent and a minimum of 13 years of related experience; or,
• Masters’ Degree in Biological Sciences, Data in a related field (e.g., Computer Science, Biology, life science) or equivalent and a minimum of 11 years of related experience; or,
• Equivalent combination of education and experience.

Experience/The Ideal for Successful Entry into Job:

Knowledge/Skills:

• Strong technical expertise in platforms like SAS, R, Python, Spotfire, and Tableau.
• Knowledge and enterprise 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 deal with a wide range of complex problems independently and through others.
• Innovative mindset, ability to think beyond traditional working methods, influence and inspire change.
• Highly developed analytical skills, conceptual thinking, and integrative vision required to drive customer needs, business performance, and risk management.
• Strong ability to explain technical concepts to non-technical members of the organization.
• Thorough knowledge of clinical development process, industry standards, and resources needed to manage trials of differing complexities.
• Tried ability to influence relevant stakeholders and global teams.
• Proven experience of success