Associate Director, Clinical Supply Chain

Neurocrine Biosciences • San Diego, CA

1d • $161,100 - $220,000

About The Position

Supports development and execution of a strategic operating plan for department wide Clinical Supply Chain design/packaging/labeling/distribution activities. Supports production, resource planning and process management to meet portfolio goals, timelines and costs in support of an expanding clinical portfolio for both large and small molecule assets. Leads in the development of company and department policies and procedures impacting overall operations, working towards efficiency and high quality GMP deliverables. Manages a subset of the Clinical Supply Chain Department, mentoring and developing staff at all levels.

Requirements

• BS/BA degree and 10+ years of relevant experience, OR Masters and 8+ years of related experience
• Drives strategic implementation of efficient solutions on highly complex Clinical Supply Chains
• Requires expertise in international Clinical packaging and distribution knowledge for both large and small molecule assets
• Requires effective communication with technical personnel both internally and externally
• Must demonstrate capabilities in all aspects of clinical packaging activities, project management, planning, budgeting, resource allocation, supervising employees, team leadership, managing third party vendors and timely goal achievement
• Must be grounded in the fundamentals of pharmaceutical development and understand all phases of clinical development (Phase 1 - Phase 4).and have advanced technical knowledge within these areas
• Extensive knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives including the role of the Qualified Person (QP)
• Skillful in collaborative platforms (e.g., SharePoint, MS Teams, Zoom), Electronic Data Capture systems, and Inventory Management systems
• Demonstrate professional capabilities in project management across multiple projects with a full understanding of packaging, labeling and distribution requirements
• Must have Clinical Protocol interpretation background to support demand forecasting
• Must have a strong working knowledge of cGMP’s and FDA requirements for IND’s and NDA’s as well as European regulatory requirements for CTR filings for providing input and review

Nice To Haves

• Experience working with Pre Filled Syringes and Auto Injector presentations

Responsibilities

• Lead and implement complex clinical packaging strategies aligned with portfolio delivery and Clinical Operations forecasts
• Execute large, international, cross-functional Clincal Supply Chain activities including collaboration with Clinical Operations to forecast drug product, budget requirements, planning, kit/label specifications, IXRS and distribution logistics
• Execute GMP clinical packaging outsourcing strategy with experience in large and small molecule assets
• Manage GMP vendor relationships, supporting selection of highly qualified third-party vendors
• Responsible for packaging configuration and design to support clinical protocols
• Review and approve packaging documentation as appropriate
• Provide leadership within the team on a day-to-day basis. Creates vision and goals to drive change and efficiency
• Support annual budgeting, contracting, scheduling, packaging, labeling and coordination of any testing required at CMO sites
• Develop proactive relationships with key business leaders ensuring entire team provides superior customer service
• Integrate and improve processes, systems, policies and procedures
• Recommend department strategies and policies. Ensures that all SOPs are followed for performing required tasks per cGMP standards and to Neurocrine expectations
• Review and approve distribution requirements, establishing distribution plans and contracts with appropriate parties
• Represent Clinical Trial Materials in project and clinical team meetings informing CMC leaders as well stakeholders as to progress, resource requirements, barriers/issues needing resolution
• Manage direct reports through education and mentoring, providing an example of innovation and excellence
• Performs other job-related duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Manager