Director of Clinical and Commercial Supply Chain

Director of Clinical and Commercial Supply Chain

Position Overview:

We are seeking a dynamic and experienced Director of Clinical and Commercial Supply Chain to join our team. In this pivotal leadership role, you will oversee and manage all aspects of supply chain operations, ensuring the seamless delivery of our products from clinical stages through to commercialization. The ideal candidate will have a proven track record in supply chain planning, product launch, vendor management, and packaging, with a strong focus on compliance, quality assurance, and continuous process improvement.

Key Responsibilities:

• Supply Chain Strategy Development: Build and drive the clinical and commercial supply chain strategy, aligning it with the company's business objectives and ensuring it supports both short-term and long-term goals.

• Label and Packaging Oversight: Lead the design, development, and qualification of clinical and commercial label and packaging, working closely with external partners to ensure adherence to regulatory standards and timely product availability.

• Vendor and Supplier Management: Select and manage relationships with key Contract Manufacturing Organizations (CMOs) for label and packaging activities. Ensure the supply chain partners deliver reliable, high-quality, and cost-effective solutions while mitigating risks associated with potential supply disruptions.

• Artwork and Serialization Compliance: Implement and oversee processes for artwork creation and serialization management to ensure product traceability and compliance with regulatory requirements, including DSCSA.

• Planning and Coordination: Lead and manage supply planning activities, ensuring timely availability of materials for clinical trials and eventual commercial distribution. Drive shipping validation studies in support of regulatory submissions (BLA).

• Continuous Improvement: Champion ongoing improvements in supply chain operations to enhance productivity, cost-effectiveness, and regulatory compliance, while fostering a culture of collaboration and problem-solving.

• Leadership & Team Collaboration: Work closely with cross-functional teams, providing guidance and leadership to ensure alignment of supply chain operations with broader company objectives. Engage with stakeholders and provide clear communication on project progress and potential risks.

Qualifications:

• Education & Experience: Bachelor's degree in Engineering or a related field, with 7-10 years of experience in a highly regulated environment, particularly in cGMP (current Good Manufacturing Practice) settings. Experience in commercial packaging design for biologics is a plus.

• Regulatory Knowledge: Previous experience managing label and packaging activities for biologics, with a strong understanding of DSCSA requirements and regulatory compliance.

• Supply Chain Expertise: Strong background in supporting IND and BLA submissions and related supply chain activities. Previous experience working with CMOs and managing third-party storage sites is highly desired.

• Problem-Solving Skills: A passion for solving complex logistical challenges and troubleshooting equipment or process issues. Ability to think critically and find innovative solutions in high-pressure situations.

• Communication & Teamwork: Excellent communication skills and the ability to work effectively in a team-based environment. Hands-on approach and a willingness to contribute in various capacities across supply chain activities.

Additional Requirements:

• Strong organizational skills and attention to detail.

• Ability to work in a fast-paced, dynamic environment and manage multiple priorities effectively.

• Demonstrated leadership and strategic thinking in prior roles, with an ability to drive operational excellence.