Job Description:
At** Allucent™**, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.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 scientist related duties**, as needed.
Requirements:
- 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:
• *Benefits of working at Allucent include:**- 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 '