Department: Global Clinical Development Operations
Reports To: Bernd Kullmann, Senior Director of Clinical Supply Chain and Logistics
Bachelor or Master Degree in Business Administration, Operations Management, or similar education required.
+8 years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
The Associate Director 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 GxP environment. Works with management to develop and implement process improvements to build the organization for the future.
- Represent the Clinical Supply Chain on Development Core Teams (DCT) and 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.
- 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.
- 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.
- Additional responsibilities as required.
- 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.
Computer Skills: Proficient in Microsoft Office applications (Word, Excel, and Outlook)
Other Qualifications: Due to global nature of company early morning or evening meeting may be required