Clinical/Commercial Supply Chain Senior Manager- Contract

Candel Therapeutics•Needham, MA

1d•Hybrid

About The Position

We are seeking a talented, self-driven, and highly motivated Clinical/Commercial Supply Chain Manager/Senior Manager (Contract) with deep expertise in supply chain management. This role is responsible for overseeing the end-to-end supply of Clinical Trial Materials (CTM) across all stages of clinical development, as well as commercial operations in the future, including packaging, labeling, and distribution. The position will also serve as a key partner to Clinical Operations, Regulatory, Quality, and clinical sites, providing guidance on all aspects of CTM, comparators, and supplemental products, as applicable.

Requirements

Must be authorized to work in US. We are unable to accommodate any sponsorships.

Nice To Haves

Bachelor’s degree with 8-10 years of experience in supply chain planning within the biotechnology or pharmaceutical industry; PMP certification is a plus.
Strong project management, organizational, and communication skills.
Ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, and resourceful.
Experience managing contract packaging and labeling vendors (strongly preferred).
Knowledge of regulatory requirements for clinical/commercial supply distribution across the U.S., APAC, and EU, including testing and labeling standards.
Experience with cold-chain logistics and shipping validation is a plus.
Solid understanding of cGMP, GCP, GDP, and global transportation regulations for pharmaceutical materials.
Experience working with Qualified Persons (QP), IRT systems, depots, and global CTM distribution.

Responsibilities

Support clinical/commercial supply activities for ongoing and new clinical trials or commercial launch to ensure on-time delivery, including demand forecasting, trial monitoring, resupply planning, IRT or inventory system setup, and distribution.
Lead the design and execution of packaging and labeling campaigns, including timeline management, documentation review/approval, and coordination with Contract Development and Manufacturing Organizations (CDMOs).
Manage CDMO relationships and provide comprehensive oversight of clinical or commercial supply activities.
Ensure uninterrupted supply of clinical trial materials for studies across U.S. and international (ex-U.S.) sites.
Support timely startup of new clinical studies by ensuring availability of required materials.
Oversee and track manual distribution activities to global clinical sites, ensuring on-time delivery.
Develop and maintain efficient processes and tracking tools for manual shipments.
Review clinical protocols and develop appropriate supply chain strategies.
Manage logistics operations, including inventory control, import/export activities, transportation, and third-party warehousing.
Act as a cross-functional liaison for inventory and distribution activities, including scheduling, issue resolution, change management, and vendor oversight.
Drive timelines for bulk manufacturing, packaging, labeling, and final release to meet forecasted demand.
Develop, maintain, and present Supply Chain dashboards to senior leadership.
Partner with Accounts Payable and Legal to ensure timely processing and approval of purchase orders, change orders, and invoices related to CDMOs.
Collaborate effectively with cross-functional teams, including Clinical Operations, Pharmaceutical Sciences, Quality Assurance, and Regulatory Affairs.