Manager, Clinical Supply Chain

Role Summary

The Manager, 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.

Responsibilities

• 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).
• Working with Clinical Operations, interpret clinical study protocols to understand clinical supply needs and 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.
• Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors.
• 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).
• 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. Serve as unblinded drug supply manager when required.
• 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
• Lead cross functional projects and process improvements related to drug supply.
• Assist in the creation of Standard Operating Procedures.
• Manage change controls for Clinical Supply Chain
• Work with Regulatory to provide to support IND or other regulatory submissions
• All other duties as assigned.

Qualifications

• At least 7+ years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
• Experience with supporting a multi-country, double-blinded study is required
• Experience working with QP and working knowledge of global regulations for investigational medicinal products, such as Annex 13 and the EU CTR & CTD.
• Experience with understanding and development of user requirements, acceptance testing, and utilization of IRT/RTSM, depots and global IP distribution.
• Experience managing the logistics of domestic and international shipments in support of clinical production.
• Demonstrates ability to champion, inspire, collaboratively create, and execute sound business processes.

Education

• BS degree in life science or technical discipline. A degree in Supply Chain Management or certification preferred.

Skills

• Strong management and organizational skills and detail orientation with an ability to prioritize, enable, and accelerate multiple programs and projects while simultaneously delivering against the activities of daily operations.
• Ability to thrive in a multidisciplinary team environment is essential for success, with a strong ability to build relationships.
• Proven agility and success in a dynamic company / business environment where change is frequent and rapid understanding and alignment is paramount.
• Computer skills including Microsoft Office Suite products and working knowledge of various operational software systems including IRT software.
• Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.
• Excellent project management and communication skills, with particular emphasis on negotiating and problem solving.