Bachelor's degree with 3-5 years of supply chain planning experience in biotech or pharma
PMP certification is a plus
Strong project management and organizational skills
Excellent communication abilities
Experience managing contract packaging and labeling vendors is preferred
Knowledge of regulatory requirements for supply distribution in U.S., APAC, and EU
Familiarity with cold-chain logistics and shipping validation is a plus
Responsibilities
Support clinical/commercial supply activities for trials and launches to ensure on-time delivery
Review clinical protocols and develop supply chain strategies
Lead packaging and labeling campaigns, managing timelines and documentation
Manage relationships with CDMOs and oversee supply activities
Ensure uninterrupted supply of clinical trial materials for U.S. and international sites
Support startup of new clinical studies by ensuring material availability
Oversee manual distribution activities to global clinical sites
Benefits
Collaborative work environment with cross-functional teams
Opportunity to influence clinical trial success and commercial operations
Access to professional development and training
Engagement in innovative projects within a fast-paced industry
Potential for career advancement in a growing company
Full Job Description
Position Overview
We are seeking a talented, self-driven, and highly motivated Clinical/Commercial Supply Chain Planning Manager/Senior Manager based in Needham, Massachusetts, will oversee the end-to-end supply of clinical trial materials across clinical development and support future commercial operations. The role combines forecasting, packaging, labeling, distribution, vendor oversight, and cross-functional coordination to ensure materials are available and delivered on time. 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.
Key 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.
Review clinical protocols and translate them into appropriate supply chain strategies.
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.
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.
Preferred Qualifications
Bachelor's degree with 3-5 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.
