Job Title: Executive Director, Head of Programming

Work Location: Remote-PST 

Summary:

The Executive Director, Head of Programming, provides strategic, technical, and operational leadership for the Programming function, overseeing a primarily in-house team supporting clinical portfolio development, global registrations, and product life cycle management. This role requires a blend of leadership, technical expertise, and hands-on problem-solving to ensure high-quality delivery across multiple programs and priorities in a fast-paced environment.

Responsibilities:

• Set strategic direction and provide technical leadership for the Programming function, ensuring accountability and high standards.
• Lead, develop, and retain a high-performing in-house programming team, fostering a culture of ownership, collaboration, and technical excellence.
• Oversee timely and high-quality programming deliverables for clinical studies, statistical analyses, regulatory submissions, and publications.
• Direct programming strategy and execution for major regulatory submissions, including NDA/BLA filings and related activities.
• Maintain and enhance in-house programming capabilities, including CDISC-compliant submission packages, Define-XML, reviewer guides, and Pinnacle 21 validation.
• Establish and improve programming standards, processes, infrastructure, and tools to drive quality, efficiency, and scalability.
• Prioritize and allocate resources across multiple studies and programs, proactively addressing resource needs and delivery risks.
• Collaborate with cross-functional teams to support integrated planning and execution, ensuring compliance with standards and regulatory expectations.

Qualifications:

• Bachelor's or advanced degree in Statistics, Biostatistics, Computer Science, or a related quantitative discipline.
• 15+ years of progressive programming experience in the biotechnology, pharmaceutical, or CRO industry.
• Significant experience leading and developing in-house programming teams in a clinical development environment.
• Direct experience with NDA/BLA regulatory submissions and FDA submission requirements.
• Expertise in SAS, CDISC SDTM/ADaM standards, TFL programming, validation, traceability, and regulatory submission processes.
• Hands-on experience with submission-ready CDISC data packages, Define-XML, reviewer guides, and Pinnacle 21.
• Demonstrated ability to operate at both strategic and detailed technical levels, resolving complex programming and submission issues.
• Strong planning, prioritization, problem-solving, and decision-making skills, with a proven track record of delivering high-quality results under tight timelines.
• Experience building, coaching, and retaining high-performing teams, with excellent communication and collaboration skills across functions and organizational levels.
• Resourceful, pragmatic leadership style with the ability to make sound trade-offs in a dynamic environment.

Published Category: Data Management & Programming