Manager, Clinical Supply & Logistics (Chicago Based)

Role Summary

The Manager, Clinical Supply and Logistics will serve as the liaison between the Clinical Research Operations and Technical Operations teams to enable cross-functional collaboration for end-to-end clinical supply chain management to support clinical trial execution. This role supports the strategic planning and execution of new clinical trial supply chains on time and within budget, and fosters an integrated operating model through close collaboration with cross-functional stakeholders. Location: Chicago (hybrid).

Responsibilities

• Oversees clinical supply labeling, packaging, release, distribution, return and destruction at contract manufacturing organizations.
• Manages inventory globally at depots and sites including order management and proof of delivery confirmation, return or destruction and distribution logistics.
• Acts as a key interface between the Technical Operations and Clinical Research Operations teams to operationalize supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
• Interprets protocol or study overview to calculate total demand and translation of total demand into a demand forecast over time.
• Manages clinical supply activities for clinical trials including clinical supply needs identification, determination of appropriate presentation to clinical site and participants and IP expiry date management.
• Collaborates with project team members including Technical Operations, Regulatory and Quality to design and implement drug labelling, packaging and supply strategies that not only meet the requirements of the study design, the clinical study sites, project timeline and the relevant regulatory authorities, but also maximizes efficiency of supply.
• Leads the logistics of the forecasting, planning, and distribution of ancillary supplies for all clinical trials in conjunction with senior team members.
• Coordinates supply strategies with internal Supply Chain/Technical Operations team and external packaging suppliers in conjunction with senior team members.
• Manages external clinical vendors including IRT vendors, as assigned, in conjunction with senior team members.
• Proactively identifies, prevents, and mitigates cross functional program risks related to clinical supply logistics.
• Work with the cross functional project team to ensure consistent communication of clinical trial material supply chain status.
• Collaborates with cross-functional study team members to ensure compliance of department/study activities with ICH guidelines, GxP, FDA and other applicable country regulations.
• Other tasks as requested by managers.

Qualifications

• Bachelor's degree (B.A./B.S.) or equivalent, preferably in life sciences or related discipline.
• 5+ years of related experience supporting clinical trial teams.
• Experience managing clinical trial vendors.
• A high level of proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is also required.
• Competencies: Teamwork & Collaboration, Attention to Detail, Analytical skills, Organizational skills, Written and Verbal Communications, Adaptability, Time Management skills.
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Chicago office. A minimum of three days per week in the office is required. On-site requirements may change at management's discretion.

Skills

• Cross-functional collaboration
• Supply chain planning and forecasting
• Inventory and vendor management
• Drug labelling, packaging, and distribution strategies
• Regulatory compliance (ICH, GxP, FDA)
• Analytical and problem-solving abilities
• Communication and project coordination

Additional Requirements

• Travel: Periodic overnight travel.