Clinical Supply Chain Manager

TScan Therapeutics•Waltham, MA

2d•Hybrid

About The Position

TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Sr. Manager, Clinical Supply Chain to oversee end-to-end supply chain activities to support our clinical studies. Reporting to the Sr. Director, Clinical Operations, the ideal candidate should have relevant experience in managing clinical supply chain activities for oncology or cell therapy products, and enjoy fast-paced, collaborative, and vibrant culture. A team player with a sense of urgency will thrive in this role.

Requirements

BS/BA or equivalent in operations, life sciences, or a health-related field.
Minimum of 8 years of experience in the pharmaceutical/biotechnology industry, with a focus on clinical supply chain, clinical trial material management, or related areas.
Strong understanding of GxP and FDA regulations governing clinical trials.
Excellent written and verbal communication skills, with the ability to collaborate effectively with cross-functional teams.
Strong interpersonal skills, with the ability to diplomatically interact with senior management, external vendors, and clinical trial sites.
Ability to prioritize tasks in a fast-paced, dynamic environment and manage multiple competing deadlines.
Familiarity with electronic chain of custody systems (e.g. TrakCel).

Responsibilities

Develop and execute global clinical supply chain strategies across multiple clinical programs.
Work closely with Clinical Operations to understand dosing timelines and place drug product orders to ensure timely delivery to clinical sites.
Ensure accuracy of drug product dosing information and approve final chain of custody and dosing documents.
Track shipments to clinical sites and triage issues during delivery ensuring adherence to timelines and quality standards.
Monitor drug product inventory levels and develop inventory trackers.
Support development and approval of text for leukopaks and drug product labels ensuring adherence to regulatory requirements.
Manage documentation related to temperature excursions during delivery and storage of drug product.
Maintain audit-ready documentation for all clinical supply chain activities and ensure compliance with GxP and relevant FDA regulations.
Develop and track budgets for all supply chain activities.
Facilitate communication and collaboration with internal teams (Clinical Operations, Regulatory, QC, QA, etc.) and external stakeholders (vendors, consultants) to ensure timely execution of clinical supply activities.
Manage interactions with clinical trial sites regarding the return and destruction of drug products.
Train clinical sites on clinical supply chain procedures.
Manage activities related to the electronic chain of custody system by managing the external vendor, managing updates to the system, conducting UAT, developing training material and training sites.
Drive process improvements and implement best practices to enhance efficiency, compliance, and scalability.