MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases. Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.
The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.
Summary of Position
The Senior Clinical Supplies Manager is a key member of the clinical development team and assists in the oversight of all aspects of clinical supply planning, forecasting, capacity planning, labeling/packaging, distribution and risk management for all MacroGenics’ clinical products/clinical trials. He/she works closely with Director, Clinical Pharmacy, Clinical Operations, Clinical Research, CMC, Regulatory Affairs CMC, Supply Chain, QA, Finance and contracted CROs and external clinical supply vendors 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 oversight of the forecasting, planning, labeling/packaging and distribution of clinical supplies and/or ancillary supplies for all clinical trials. This also includes site training, expiry date management, regulatory requests and overall supply management.
- Responsible for the oversight of forecasting individual study initial and resupply drug needs and collaborates on supply strategies with Supply Chain colleagues. Responsible for assisting in the 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. Recommend changes to labeling/packaging schedules for clinical drug products based on study progress and or any changes with the study plans
- Partners with the clinical team to evaluate and select vendors as needed. Manages activities of third party vendors including CMOs, clinical supply packaging and labelling vendors, translations agencies, regional and local depots and domestic and worldwide couriers. Works closely with all internal and external resources to optimize clinical supply availability and inventoryinvestment.
- Works closely with internal colleagues and external partners to proactively manage clinical and ancillary supply and comparator drug inventories as required. Maintain inventories and provides study, region and country inventories for all MacroGenics clinical products.
- Oversees and actively manages relationships with contract clinical labeling/packaging/distribution vendors to ensure production and inventory targets are communicated and met.
- Develops and manages strategic alliances with contract partners for procurement, packaging, transportation, brokerage, storage and distribution.
- Manages the clinical packaging vendors to develop the optimal packaging and resupply schemas, develop supply strategies, manage depot/site distribution/stocking requirements, and manage expiration/retest date requirements. Develops and communicates accurate lead time requirements to clinical packaging/distribution vendors as well as internal Supply Chain.
- Works with Director, Clinical Pharmacy to review and develop procedures and processes to manage the growth of clinical supplies and the increasing number of clinical trials being conducted by MacroGenics
- Initiates clinical supply carton and label design, including blinded kit packaging and randomization schemes.
- Work with Director, Clinical Pharmacy to aid in the development and management the annual Clinical Pharmacy budget based on approved clinical and project plans. Raises issues or concerns to manager with recommendations for resolution.
- Review and approve monthly invoices for assigned clinical trial activities and review for accuracy and track any discrepancies to resolution.
- Supports systems implementation, reports and SOP creation as required.
- Performs other functions as necessary or as assigned.
Bachelors in Pharmacy or related science degree
- Minimum of seven (7) years of proven experience in related clinical supply management roles 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, labeling and distribution
- Prior experienceworking with all levels of management and consulting with key business stakeholders.
- Broad experience of GMP and GDP operations and a proven track record of successfully leading and contributing to cross-functional teams are a key requirement.
- Must have experience with assisting in the development of project specific budgets as well as resource planning.
Knowledge, Skills and Abilities
- Individual must possess the ability to influence without direct authority.
- Detailed knowledge of GCP, cGMP and GDP regulations pertaining to the procurement, manufacture, and distribution of clinical supplies.
- Must have knowledge of US and Global clinical labeling regulations and requirements.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Excellent communication and collaboration skills across levels and functions.
- Results driven with demonstrated successful outcomes.
- Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).
- Up to 10% travel may be required.