MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer.Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology 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 Clinical Supplies Manager 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 Supplies, 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 clinical trials.

Responsibilities

• 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.
• Responsible for the oversight of forecasting individual study initial and resupply drug needs and collaborates on supply strategies with Supply Chain colleagues.
• Assists 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.
• Recommends 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 labeling 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 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.
• 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 Supplies 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.
• Reviews and approves monthly invoices for assigned clinical trial activities and review for accuracy and track any discrepancies to resolution.
• Supports systems implementation and report development.
• Participates in SOP creation as required.
• Performs other functions as necessary or as assigned by department manager.

Qualifications:

Education/Experience

• Bachelors Degree, preferably in pharmacy or related science degree with a minimum of five (5) of experience in the clinical supplies process, project management or inventory management with at least two (2) years of proven experience in related clinical supply management roles in the pharmaceutical/biotech industry

Or

• HS Diploma, with a minimum of seven (7) years of experience in the clinical supplies process, project management or inventory management with at least two (2) years of proven experience in related clinical supply management roles in the pharmaceutical/biotech industry

And

• Two (2) years of experience in the set-up, management, and close-out of phase 1-4 global clinical trial supply programs
• Two (2) years of experience with overseeing and directing clinical supply activities including packaging, labeling, distribution, returns, accountability and destruction
• Prior experience working with and consulting with key business stakeholders.
• 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

• Knowledge of GCP, cGMP and GDP regulations pertaining to the procurement, manufacture, and distribution of clinical supplies is required
• Individual must possess the ability to influence without direct authorityAbility 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 deadlinesStrong organizational and self-management skills
• Exemplary teamwork and interpersonal skills
• Strong customer service orientation
• Strong Project Management skills
• 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, Excel, Powerpoint, MS Project, Excel)
• Must be able to travel approximately 10% of the time

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled