Senior Director, CMC

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• At **Allucent™**, we are committed to assisting small to medium-sized biopharmaceutical companies in effectively navigating the intricate landscape of clinical trials to deliver transformative therapies to patients worldwide.

• In the role of Sr. Director, CMC, you will:

• - **Oversee comprehensive CMC strategy** encompassing drug substance, drug product, and analytical development—from initial evaluation through regulatory submission and commercial launch, prioritizing scientific elements.

• - **Promote regulatory excellence** by drafting and reviewing CMC submissions, managing communications with Health Authorities, and ensuring adherence to FDA, EMA, and ICH standards.

• - **Develop product development plans** from early stages through Phase 4.

• - **Supervise and mentor direct reports** through development and performance management while providing training on existing and new regulatory standards.

• - **Execute additional scientist-related responsibilities** as necessary.

⛳️ Requirements

• - A B.S., R.Ph., M.S., Ph.D., or an equivalent qualification in a scientific discipline, along with a relevant combination of experience in drug, biologic, or device development.

• - In-depth scientific and regulatory understanding of drug, biologic, or device development.

• - Experience with pre-approval products; significant experience with large biologics required.

• - Line management experience is essential.

• - Previous experience in a CRO is preferred.

• **Skills:**

• - Strong critical thinking and analytical abilities, financial insight, capability to influence and lead teams, risk assessment skills, and excellent written and verbal communication skills in English.

• - Proficient computer skills, including SharePoint, Word, Excel, and PowerPoint.

• - A focus on quality.

• - High emotional intelligence, customer-centric leadership, and decision-making abilities.

• - Innovative, creative, and practical problem-solving skills.

• - Over 10 years of directly relevant experience in drug, biologic, or device development is desirable.

🏝️ Benefits

• **The advantages of working at Allucent include:**

• - A comprehensive benefits package tailored to each location.

• - Competitive salaries based on location.

• - A departmental Study/Training Budget to promote professional development.

• - Flexible working hours (within reason).

• - Opportunities for remote or hybrid working depending on location.

• - Leadership and mentoring opportunities.

• - Participation in our Buddy Program, whether you are a new or existing employee.

• - Internal growth opportunities and pathways for career advancement.

• - A financially rewarding internal employee referral program.