Pliant Therapeutics is a clinical stage biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. The company’s focus is on mechanism-based intervention in the fibrotic process using small molecules. The company’s lead product candidate, PLN-74809, is designed to be a selective inhibitor of αvβ1 and αvβ6 integrins that play a key role in multiple fibrotic pathways. 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. The Company is seeking passionate, creative and dedicated individuals to join our team and contribute to our mission.
The role will partner closely with Clinical Operations to oversee clinical supply storage, packaging, labeling, distribution and reverse logistics associated with clinical trials. The Senior Specialist, Clinical Supply Chain will successfully manage these activities in conjunction with AD Clinical Supply Chain Management, Quality Assurance, and Pliant third-party service providers to ensure that clinical supply is available to meet trial demand. Responsibilities further include preparing metrics and monitoring operational performance across the clinical value chain.
Essential Functions, but are not limited to
- Manage daily order intake and distribution activities with all third-party service providers, ensuring right the first-time order submission and on-time delivery to clinics.
- Supports clinical study management team demand planning, distribution, inventory management, and execution of packaging and labeling operations at third-party service providers.
- Single point of contact for all clinical trial distribution activities throughout the duration of a study.
- Provide a responsive, effective and high level of customer service to Pliant’s Clinical Operations team.
- Author policies and procedures required for clinical supply chain activities to ensure GMP compliance.
- Support forecasting and capacity planning to ensure uninterrupted clinical supply.
- Pro-actively identify potential shipment delays and escalate as needed.
- Support selection, URS/UAT, configuration and management of clinical trial management E-Systems, IRT systems, etc.
- Perform root cause analysis associated with supply disruptions, including but not limited to transit delays, temperature excursions, etc.
- Participate in cross-functional distribution related projects and process improvement initiatives.
- Create and manage purchase orders and track budget adherence associated with clinical supply activities.
- Remain current with industry trends and best practices as well as changes in the regulatory landscape related to clinical supply chain.
- Other duties as assigned
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, and/or ability expected.
- Strong working knowledge of clinical trial demand forecasting and 3PL supply strategy.
- Direct experience interfacing with clinical IRT systems; experience implementing a clinical IRT system preferred.
- Demonstrated experience identifying, onboarding and managing 3PLs, including contract negotiation & budget oversight.
- Strong working knowledge of clinical packaging and labeling operations, as well as associated quality and regulatory requirements.
- Knowledge of import/export requirements associated with Synthetic clinical product to ex-U.S. locations preferred.
- Candidates must be authorized to work in the U.S.
- 1 to 2 years of relevant experience with an MS degree or 2 to 3 years of relevant experience with a BS/BA or 3+ years relevant experience with an AS degree. Degree in Business, Supply Chain Operations, or engineering field strongly preferred, but not required.
- Knowledge of cGMP quality systems.
- Understanding of drug product CMC activities.
Knowledge, Skill and Abilities
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.