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.
• Perform other related duties, as needed.

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
• >10 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program