Director, Clinical Supply Chain Management

The Director of Clinical Supply Chain (CSC) is a key function at the junction of Clinical Operations, Regulatory Affairs, and CMC organizations. The position is responsible for ensuring compliant, uninterrupted end to end supply of investigational products. Will also be responsible for developing and implementing required Clinical Supply Chain procedures and infrastructure to support Pliant's development pipeline.

• Develop Supply Chain Management strategies to maximize supply efficiency, minimize waste. Ensure the CSC team develops IMP demand and supply plans that support study timelines and incorporate risk mitigation plans to ensure timely and uninterrupted supply. Collaborate with other CMC teams to optimize end-to-end inventory strategies.
• Manage contract manufactures performing primary packaging, labeling, and global distribution. Lead the evaluation, selection, and ongoing oversight of CMO operations to ensure they are effective members of the Pliant global Supply Chain. Collaborate with QA for appropriate quality audits and evaluations.
• Lead the development of compliant IMP labels in collaboration with Clinical Operations, RA, and QA to ensure all label text and proofs are in accordance with applicable regulations, product specifications, and clinical study protocols.
• Perform demand and supply planning and forecasting for all Pliant's development program. Evaluate impact of changing inventory targets, clinical demand and budget needs.
• Develop Supply Chain Management strategies to maximize supply efficiency, minimize waste. Ensure the CSC team develops IMP supply plans that support study timelines and incorporate risk mitigation plans to ensure timely and uninterrupted supply. Collaborate with other CMC teams to optimize end-to-end inventory.
• Lead, develop and mentor the Clinical Supply Chain team. Create a compelling vision for Clinical Supply Chain that generates cross-functional support and integrates with future commercialization strategies.
• Collaborate with Program Management, Clinical Operations, and Regulatory Affairs (RA) on clinical studies program strategies, scope, and study demands, ensuring alignment with CMC capabilities, supply plans, and timelines. Ensure all plans effectively incorporate CMC capacity and lead times.
• Partner with Clinical Operations for evaluation and selection of CRO partners and IRT/IxRS vendors. Collaborate regarding CRO capabilities to support study execution of IMP supply, including global depot networks and IRT/IxRS functionality, as necessary.
• Collaborate with Clin Ops and Data Management for the creation of User Requirements Specifications (URS) and effective end-to-end UAT testing. Together with the CSC team, ensure that the IRT/IxRS is optimally configured and utilized effectively to maintain continuous IMP supplies.
• Manage the IMP global logistics network leveraging CMO and other logistics and global trade compliance business partners to ensure timely and compliant movement of Pliant IMP products (including drug substance, drug product and any cGMP materials).
• Serve as internal lead for triaging of product complaints, temperature excursions, and deviations originating from distribution vendors and clinical sites. Partners with Quality Assurance to resolve any quality related items in a timely manner.

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• M.S. or B.S in scientific or business discipline and 10+ years' experience in Clinical Supply Chain, including 3+ years of managing a team.
• Management and Logistics in biotech/pharmaceutical industry with increasing scope of responsibilities.
• Solid understanding of global pharmaceutical regulatory requirements and clinical study management. Working knowledge of GMP/GCP/GLP regulations.
• Experience developing Supply Chain strategies, garnering support from other functional teams, generate support and commitment from Supply Chain team members.
• Knowledge of IRT functionality, system setup and operation.
• Experience in IMP demand and supply planning, scenario planning and risk modeling; proficiency with Excel based models.
• Experience in recruiting and developing team members and creating a healthy, robust Clinical Supply Chain team.
• Effective communication, interpersonal skills, collaboration, and negotiation skills
• Excellent time management and project management skills, and ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team.
• Ability to operate in alignment with Pliant's core values.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $225,000 - $235,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant's compensation package also includes benefits, equity, and annual target bonus for fulltime positions.