Clinical Supplies Manager/Senior Clinical Supplies Manager

Role Summary

The Clinical Supplies Manager/Senior Clinical Supplies Manager is responsible for all aspects of clinical supply planning, forecasting, capacity planning, labeling/packaging, distribution and risk management for MacroGenics’ clinical products and clinical trials. This role collaborates with Clinical Operations, Regulatory Affairs CMC, Supply Chain, QA, Finance, Program and Portfolio management, external clinical supply vendors and CROs to forecast and manage clinical supply and ancillary supply needs and timelines for all clinical trials.

Responsibilities

• Collaborates cross-functionally with internal and external partners to determine clinical supply needs throughout the life of the study, forecasting and overseeing planning, labeling/packaging, and distribution of clinical and ancillary supplies for all trials.
• Forecasts initial and resupply drug needs for individual studies and collaborates on supply strategies with Supply Chain colleagues.
• Manages clinical and ancillary supply and comparator inventories with internal and external partners; maintains inventories and provides study/region/country inventory data for MacroGenics products.
• Develops secondary packaging and labeling strategies to support trials (global and domestic, all phases) in line with study timelines; recommends labeling/packaging schedule changes as needed.
• Initiates clinical supply carton and label design, including blinded kit packaging and randomization schemes.
• Oversees relationships with third-party vendors (CMOs, packaging/labeling vendors, translation agencies, depots, couriers) and ensures targets are met.
• Manages packaging vendors to develop optimal packaging and resupply schemas; manages depot vendors to meet distribution/stocking requirements; monitors expiration/retest dates to minimize wastage.
• Develops lead time requirements and communicates them to internal stakeholders and vendors.
• Collaborates with the Associate Director, External Supply Operations to review procedures, support systems implementation, reporting, and SOP creation as required.
• Assists in developing and managing the annual Clinical Supply Operations budget based on approved plans; raises issues with recommendations for resolution.
• Reviews and approves monthly invoices for accuracy and resolves discrepancies.
• Performs other functions as necessary or assigned.

Qualifications

• Bachelor‚Äôs degree in pharmacy or related science or equivalent education/experience.
• Clinical Supplies Manager: Minimum of five (5) years of experience in clinical supply management roles and/or project management in the pharmaceutical industry; at least two (2) years in setup, management, and close-out of phase 1-4 global clinical trial supply programs; at least two (2) years overseeing packaging, labeling, distribution, returns, accountability and destruction; at least two (2) years managing multiple domestic and international trials.
• Senior Clinical Supplies Manager: Minimum of seven (7) years of experience in clinical supply management roles and/or project management; at least five (5) years in setup, management, and close-out of phase 1-4 global clinical trial supply programs; at least five (5) years overseeing packaging, labeling, distribution, returns, accountability and destruction; at least five (5) years managing multiple domestic and international trials.

Knowledge, Skills And Abilities

• Knowledge of GCP, cGMP and GDP regulations related to procurement, manufacture, and distribution of clinical supplies.
• Familiarity with global clinical labeling regulations and requirements.
• Familiarity with project-specific budgeting and contract management.
• Ability to influence without direct authority; ability to work independently and collaboratively in a fast-paced, matrixed environment.
• Analytical thinker with strong problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Strong organizational, planning, and time management skills with the ability to prioritize multiple projects.
• Strong project management skills and excellent communication and collaboration across levels and functions.
• Results-driven with demonstrated successful outcomes.
• Proficiency in Microsoft Word, Excel, PowerPoint, MS Project.
• Travel up to 10% may be required.

Education

• Bachelor‚Äôs degree in pharmacy or related science or equivalent combination of education and experience.

Additional Requirements

• None