The Director of Clinical Pharmacy is a key member of the clinical development team and oversees 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 Clinical Operations, Clinical Research, CMC, Biopharmaceutical Development & Manufacturing, QA and contracted CROs to forecast and manage clinical 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, planning, labeling/packaging and distribution of all required clinical trial including site training, expiry management, regulatory requests and overall supply management
Responsible for forecasting individual study initial and resupply drug needs, and collaborating on manufacturing strategies with CMC colleagues. Responsible for developing the overall secondary packaging and labeling strategy to support individual study 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, 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 inventory investment.
Works closely with internal colleagues and external partners to proactively manage clinical supply inventories. Maintains molecule inventories and provides study, region and country inventories for all MacroGenics clinical products.
Maintains accurate inventories for comparator drugs and ancillary supplies used in all MacroGenics clinical studies.
Oversees and actively manages relationships with labeling/packaging/distribution Contract Manufacturing Organizations 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 packaging vendors to develop the optimal packaging schemas, develop supply strategies, manage depot/site distribution/stocking requirements, and manage expiration/retest date requirements. Develops and communicates accurate lead time requirements to our packaging/distribution vendors as well as the internal Biopharmaceutical Development & Manufacturing teams
Recommends new procedures and processes to manage the growth of clinical supplies and number of clinical trials being conducted by MacroGenics
Initiates clinical Finished Drug Product carton and label design, including blinded kit packaging and randomization schemes
Develop and manage the annual Clinical Pharmacy budget based on approved clinical and project plans. Raises issues or concerns to manager with recommendations for 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
Ten (10) years of proven experience in related clinical supply management roles in the pharmaceutical industry
Seven (7) years of experience in the set-up, management, and close-out of phase 1-4 clinical trial supply programs.
Six years (6) of experience with overseeing clinical supply activities including packaging, labeling, distribution, returns, accountability and destruction
Five years (5) of experience managing multiple domestic and international trials, including drug projections, packaging, labeling and distribution
Prior experience working with all levels of management and consulting with key business stakeholders.
Broad experience of GMP operations and a proven track record of successfully leading and contributing to cross-functional teams are a key requirement.
Must have experience with developing 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 and cGMP 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
Ability to problem solve in a fast paced, complex environment
Results driven with demonstrated successful outcomes.
Must be proficient in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).
Must also be able to facilitate occasional projects not possible during normal business hours due to vendor necessity or customer impact (e.g. ability to be on call for any critical system issues).
Up to 10% travel may be required
Internal Number: 2018-1124
About MacroGenics, Inc.
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.