Department: Clinical Supply Chain and Logistics
Reports To: TBD, Associate Director of Clinical Supply Chain and Logistics
(interim reporting to Bernd Kullmann, Senior Director)
Bachelor or Master Degree in Business Administration, Operations Management, or similar education required.
+6 years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
Hours: 40 hours/week
Over-time may be required on occasion
The Manager of Clinical Supply Chain and Logistics manages drug supply activities related to planning, label development, label & pack, and distribution for several clinical studies. Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Represents Supply Chain to internal stakeholders and coordinates activities 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 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.
- Ensure 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.
- Coordinate daily activities for FG label & pack CMOs and distribution vendors as required.
- 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 shipments to depots and clinical sites. Maintain and track import licenses.
- Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Support 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.
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Proficient in Microsoft Office applications (Word, Excel, and Outlook), IRT Systems
Other Qualifications: Due to global nature of company early morning or evening meeting may be required