Sr. Director, CMC

About the role

As the Sr. Director, CMC, you will:

• Lead end-to-end CMC strategy across drug substance, drug product, and analytical development—from early-stage evaluation through regulatory submission and commercial launch with a focus on scientific aspects.
• Drive regulatory excellence by authoring and reviewing CMC submissions, leading Health Authority communications, and ensuring compliance with FDA, EMA, and ICH guidelines.
• Prepare product development plans from early development through Phase 4.
• Manage and lead direct reports through development and performance management and by providing training on current and new regulatory requirements.

Requirements

• Minimum 9 years as a CMC strategy consultant as an independent contractor/consultant or as an employee at a CRO
• Requires a B.S., R.Ph., M.S., Ph.D., or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development
• Advanced scientific and regulatory knowledge of drug, biologic, or device development
• Experience in pre-approval products; large biologics experience required
• Line management experience required
• Prior CRO experience preferred

Skills

• Critical thinking and analytical skills
• Financial acumen
• Influencing and leading teams
• Risk assessment
• Strong written and verbal communication skills in English
• Strong computer skills, including SharePoint, Word, Excel, and PowerPoint
• Quality focus
• Strong emotional intelligence, customer focused leadership and decision-making skills
• Innovative, creative, and practical thinking including problem-solving skills
• More than 10 years' post-degree of directly relevant experience in drug, biologic, or device development desirable