Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant seeks to develop targeted treatments to slow or halt the progression of multiple life-threatening fibrotic diseases. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6 integrins, which play key roles in multiple fibrotic pathways. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration in both idiopathic pulmonary fibrosis (IPF) and primary sclerosing cholangitis (PSC), and is currently in Phase 2 testing for IPF. Pliant’s second product candidate, PLN-1474, is designed to be an oral, small molecule selective inhibitor of αvβ1, targeting late-stage liver fibrosis and is partnered with Novartis.
Position Overview: The Sr. Manager/Associate Director of Clinical Supply Chain is a key function at the junction of clinical operations and CMC organizations, responsible for forecasting and tracking clinical trial supplies.
- Work with Clinical Operations to understand clinical study demand requirements and ensure alignment with CMC to supply plans and timelines
- Manage GMP inventory (both drug product and drug substance) throughout the supply chain, develop inventory reports, manage upcoming expiry and temperature excursions, and ensure drug accountability
- Support the evaluation, selection and quality audit of packaging/labeling and distribution vendors
- Coordinate daily activities with distribution vendors as required
- Serve as internal lead for triaging of product complaints, temperature excursions, and deviations originating from distribution vendors and clinical sites.
- Investigate deviations to determine root causes and implement corrective actions
- Ensure label text and proofs are in accordance with applicable regulations, product specifications, and clinical study protocols
- Support IRT user acceptance testing, supply strategy, and oversee ongoing supply activities in system
- Provide expert input on ex-US importation requirement
- Coordinate import/export activities and track shipments to depots and clinical sites.
- Ensure all necessary documentations are available to the clinical sites
- Develop supply chain management strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Establish internal SOPs for supply chain management related activities
- B.S. or M.S in scientific or health related field with 7+ years’ experience in Clinical Supply Chain Management
- Understands comprehensive global pharmaceutical regulatory requirements
- Knowledge of IRT system setup and functionality and proficiency with Excel modeling of supplies
- Knowledge and understanding of international pharmaceuticals shipping requirements
- Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Effective communication, interpersonal skills, collaboration and negotiation skills
- Highly organized and efficient, able to orchestrate multiple projects simultaneously
- Excellent project management skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication.
- Ability to operate in alignment with Pliant’s values