Manager, Clinical Supply Chain

General Description:

The Manager of Clinical Supply Chain manages drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners. Has a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a cGMP environment. Works with management to develop and implement process improvements to build the organization for the future.

Essential Functions :

• Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).

• Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines. - Create supply and inventory plans and develop production schedules for clinical trial materials.

• Monitor schedule adherence of production schedules and make course corrections if needed. - Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.

• Oversee daily activities for FG label & pack CMOs and distribution vendors with internal stakeholders.

• Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.

• Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).

• May coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs.

• Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.

• Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.

• Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans

• Supports functional projects and process improvements related to drug supply. Assist in the creation or revision of process documents such as Standard Operating Procedures.

• Ensure staff who are in supportive roles for supply planning and business process development are meeting deliverables for successful study management

Supervisory Responsibilities:

• Demonstrates knowledge of global clinical trials and the drug development process.

• Experience in vendor oversight and managing external partnerships and relations.

• Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).

• Experience in deviation investigation and CAPA implementation. Knowledge of IRT system setup and functionality and proficiency with Excel modeling.

• Strong analytical, problem solving, and communication skills.

• Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.

• Experience in deviation investigation and CAPA implementation.

Education/Experience Required:

• Bachelor or Master Degree in Business Administration, Operations Management, or similar education required.

• Minimum 5 years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.