Associate Director, Clinical Process Engineer

Associate Director leading clinical process engineering methodology and standards across Clinical Development Operations at a regulated pharmaceutical organization. Establishes governance infrastructure, advises executive leadership on process strategy, and builds enterprise-wide capability while ensuring compliance and inspection readiness.

Responsibilities

• Define and govern clinical process engineering methodology, standards, and toolset; drive adoption across enterprise
• Serve as subject matter authority advising senior leadership on process strategy and capability investments
• Oversee design and governance of end-to-end clinical processes; ensure scalability and inspection readiness
• Lead enterprise assessments and strategic analyses; translate findings into improvement roadmaps for executives
• Establish compliance, inspection readiness, and quality-by-design frameworks; manage risk proactively

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 required
• Minimum 8 years process design, engineering, or improvement experience in regulated environments
• Deep expertise in clinical development operations, regulatory frameworks, and inspection readiness
• Expert proficiency in process mapping, methodology development, and governance design
• Demonstrated experience leading enterprise-level, multi-stakeholder programs with executive presence
• Proven track record leading high-performing teams in complex, matrixed global organizations