Senior Director, CMC

🕒 June 2

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👔 Director

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Allucent

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.

📋 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 '