Helping bring new therapies to light
Senior Director, CMC
Location
North Carolina
Posted
16 days ago
Salary
0
Seniority
Senior
Job Description
Senior Director, CMC
Allucent
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.
Job 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 '
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