Clinical Supplies Manager​/Senior Clinical Supplies Manager

Summary of Position

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 all Macro Genics' clinical products/clinical trials. This individual works closely 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.

• Collaborates cross-functionality with internal and external partners to determine clinical supply needs throughout the life of the study. Responsibilities include forecasting and oversight of the planning, labeling/packaging and distribution of clinical supplies and/or ancillary supplies for all clinical trials. Works closely with all internal and external stakeholders to optimize clinical supply availability and inventory investment.
• Responsible for forecasting individual study initial and resupply drug needs and collaborating on supply strategies with Supply Chain colleagues.
• Works closely with internal colleagues and external partners to proactively manage clinical and ancillary supply and comparator drug inventories as required. Maintains inventories and provides study, region and country inventories for all Macro Genics clinical products.
• Responsible for development of the overall secondary packaging and labeling strategy to support individual clinical trials (global and domestic, all phases) in accordance with study and program timelines.
  • Recommends changes to labeling/packaging schedules for clinical drug products based on study progress and/or any changes with the study plans.
  • Initiates clinical supply carton and label design, including blinded kit packaging and randomization schemes.
• Oversees and actively manages relationships with third-party vendors including CMOs, clinical supply packaging and labeling vendors, translations agencies, regional and local depots and domestic and worldwide couriers.
  • Ensures production and inventory targets are communicated and met by contract clinical labeling/packaging/distribution vendors.
  • Manages the clinical packaging vendors to develop the optimal packaging and resupply schemas.
  • Manages the clinical depot vendors to meet depot/site distribution/stocking requirements.
  • Monitors expiration/retest dates to ensure prompt implementation to minimize wastage.
• Develops and communicates accurate lead time requirements to internal stakeholders and clinical packaging/distribution vendors.
• Works with Associate Director, External Supply Operations to review and develop procedures and processes for clinical supplies operations and clinical trials being conducted by Macro Genics. Supports systems implementation, reports and SOP creation as required.
• Works with Associate Director, External Supply Operations to aid in the development and management of the annual Clinical Supply Operations budget based on approved clinical and project plans. Raises issues or concerns to manager with recommendations for resolution.
• Reviews and approves monthly invoices for accuracy and track any discrepancies to resolution.
• Performs other functions as necessary or as assigned.

Education/Experience

Clinical Supplies Manager

• Bachelor's degree in pharmacy or related science degree or a combination of equivalent education and years of experience.
• Minimum of five (5) additional years of proven experience in related clinical supply management roles and/or project management in the pharmaceutical industry
• Minimum of two (2) years of experience in the set-up, management, and close-out of phase 1-4 global clinical trial supply programs
• Minimum of two (2) years of experience with overseeing and directing clinical supply activities including packaging, labeling, distribution, returns, accountability and destruction
• Minimum of two (2) years of experience managing multiple domestic and international trials, including drug projections, packaging, labelling and distribution

Senior Clinical Supplies Manager

• Bachelor's degree in pharmacy or related science degree or a combination of equivalent education and years of experience.
• Minimum of seven (7) additional years of proven experience in related clinical supply management roles and/or project management in the pharmaceutical industry
• Minimum of five (5) years of experience in the set-up, management, and close-out of phase 1-4 global clinical trial supply programs
• Minimum of five (5) years of experience with overseeing and directing clinical supply activities including packaging, labeling, distribution, returns, accountability and destruction
• Minimum of five (5) years of experience managing multiple domestic and international trials, including drug projections, packaging, labelling and distribution

Knowledge,

Skills and Abilities

Clinical Supplies Manager

• Knowledge of GCP, cGMP and GDP regulations…