Clinical Supply Chain Manager

Neurocrine Biosciences

1d

About The Position

Support activities related to Clinical Trial Material (Phase 1-4); providing support to the Director, Clinical Supplies, cooperate with internal and external customers and partners in compliance with multinational regulations as well as internal procedures and GxP requirements. Responsible for supporting and/or managing complex studies requiring Clinical Supplies project management, forecasting, IXRS, distribution, and supply logistics such as packaging/labeling and global distribution. This position will interface with Clinical, Project Management, Regulatory, QA, Manufacturing and teams. The Senior Specialist, Clinical Supplies will work with vendors involved in the planning, distribution, storage and destruction of Clinical trial supplies for Clinical investigational sites as required.

Requirements

• BS/BA degree in supply chain, operations management or science-related field AND 8+ years of clinical supply chain management experience; Experience IRT/IXRS/IWVR required. Experienced in building and managing forecasts for clinical supply chains. Experience with cGMPs, GCPs, and other regulatory requirements
• OR Master’s in supply chain, operations management or science-related field preferred AND 6+ years of similar experience noted above
• Good knowledge of formulation and manufacture of small molecules for use in the pharmaceutical industry
• Must have demonstrated capabilities in Drug Product Manufacturing activities, project management, planning, budgeting, managing third party vendors and timely goal achievement
• Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
• Proficiency in collaborative platforms (e.g., SharePoint, MS Teams, Zoom), Electronic Data Capture systems, and Inventory Management systems
• Strong working knowledge of FDA clinical trial material requirements for IND’s and NDA’s as well as European regulatory requirements for dossier filing input and review
• Strong understanding of distribution practices including cold chain. Understand managing blinded clinical studies and what is required to protect that blind
• Grounded in the fundamentals of pharmaceutical development with advanced packaging and labeling technical knowledge along with an understanding of Regulatory, Manufacturing and Analytical interactions and requirements
• Must have demonstrated strong 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
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills, with proficiency in Microsoft applications
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Effective communication with technical personnel both internally and externally
• Ability to establish and meet multiple concurrent priorities and deadlines

Responsibilities

• Lead CTM supply chain activities starting with collaborating with Clinical Operations to forecast all required products per clinical study including Investigational Products (IP), ancillary components and comparators/background medications that are required
• Plan and design packaging configurations to support clinical protocols as needed
• Review and approve all required documentation for CTM packaging. This will include label generation, translations management, component specifications, bottling, blistering, kitting at a minimum.
• Work collaboratively with internal departments to produce products meeting appropriate requirements
• Establish distribution requirements and set up distribution plans and contracts with appropriate parties
• Establish IRT requirement and manage CTM supply within the IRT throughout a clinical study
• Manage vendors, including to identify, evaluate and ensure outsourced vendors have the required expertise, capabilities and quality/compliance standards to support drug product manufacturing, packaging, labeling, distribution, storage and destruction processes
• Create, review and approve all required documentation for engaging CMOs, including budget review, contract review, scheduling, manufacturing, packaging, labeling & testing of drug products at CMO sites
• Develop and support all SOPs required to perform required tasks per cGMP standards and Neurocrine expectations
• As a project member or leader, may represent Pharmaceutical Operations in Company-CMO project team meetings. Inform Pharmaceutical Operations leaders as well stakeholders as to progress, resource requirements, barriers/issues needing resolution and timelines
• Provide operational support services to the CMC Development and Commercial Supply Chain/Manufacturing functions to include management of Stability Packaging operations
• Other 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 in accordance with the terms and conditions of the applicable plans

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees