Nurix, Inc. is seeking an AD/Director of Clinical Supply Chain to join the Clinical Development team. This individual will be responsible for heading the global Supply Chain Management for Nurix’s clinical programs.
This individual will be have broad involvement in work central to Nurix’s strategic goals. They will apply existing technical skills, learn new skills, and play a key role in development of the programs and help grow the company. As an early hire, They’ll be influential in championing and developing Nurix’s culture.
This person is primarily responsible for managing and ensuring timely supply of clinical trial materials for multi-national clinical studies at all stages of development. Responsibilities include cross functional planning for clinical demand and forecasting, management of storage, packaging and distribution vendors, inventory management at depots and sites, order management, import and export of GMP drug substance and drug product, returns and destruction.
- Develop clinical supply chain strategies including packaging configurations and distribution plans for supporting multinational clinical trials
- Develop strategy for clinical supply and inventory management function of IVRS/IRT. Establish and maintain a tracking system to document the detailed usage history of all drug lots for each clinical trial.
- Support labelling & packaging operations for clinical studies at all stages of development
- Develop clinical trial material forecasts to inform plans for drug product manufacturing.
- Coordinate and manage distribution of Investigational products to depots and ensure uninterrupted supply to sites for clinical studies
- Manage clinical packaging/distribution vendors including negotiating contracts, reviewing batch documentation, designing and developing distribution instructions
- Serve as the interface between the CMC and clinical teams to ensure smooth conduct of clinical studies.
- Develop, review and prepare departmental SOPs and ensure compliance with industry standards
- Coordinate import and export of GMP materials.
- Maintain inventory database, systems and documentation related to material receipt, storage and distribution in compliance with regulatory requirements.
- Ensure compliance with Good Manufacturing Practices (GMP) and applicable state and federal regulatory requirements
- Drafts strategic plans/objectives for functional unit and has control of planning, staffing, budgeting, managing priorities and recommending and implementing changes to methods within the function.
Experience and Skills:
- B.S./ B.A. in biological sciences, advanced degree preferred with 10+ years of relevant industry experience
- Demonstrated knowledge of FDA, CMC, GMPs, quality, clinical operations and blinding practices, and IRT/IWRS systems
- Experience in leading teams, consultants and vendors.
- 10-15 years industry experience in supply chain management with early and late stage) experience.
- Commercial product distribution experience is a plus
- Experience with budgeting and managing contract organizations for clinical labeling, packaging and distribution
- Working knowledge of import and export requirements in a regulated environment.
- Ability to work effectively and independently, with functional counterparts located in the USA and abroad
- Team player with demonstrated strong interpersonal skills, clear oral and written communication skills