Associate Director, Clinical Process Engineer

Associate Director role establishing clinical process engineering methodology, standards, and governance infrastructure across Clinical Development Operations. Acts as enterprise subject matter authority on process design, leading enterprise-wide assessments, workshops, and transformation initiatives while managing compliance and inspection readiness frameworks.

Responsibilities

• Define, own, and evolve clinical process engineering methodology, standards, and toolsets across the enterprise
• Serve as subject matter authority advising senior and executive leadership on process strategy and capability investments
• Oversee design and governance of end-to-end clinical processes ensuring scalability and inspection readiness
• Lead enterprise assessments and translate findings into capability recommendations and improvement roadmaps
• Establish process compliance, quality-by-design, and inspection readiness frameworks; manage audit readiness

Requirements

• Bachelor's degree in engineering, life sciences, business, or related field; advanced degree strongly preferred
• Lean Six Sigma Black Belt or equivalent preferred; Green Belt certification required
• Minimum 8 years progressive experience in process design, engineering, or improvement within regulated environments
• Deep expertise in clinical development operations, regulatory frameworks, and inspection readiness
• Expert proficiency in process mapping, methodology development, and governance design
• Proven ability to lead enterprise-level multi-stakeholder programs with executive presence
• Strategic analytical skills and demonstrated experience with large-scale process-to-system transformation programs