[Hiring] Clinical Supply Specialist @4D Molecular Therapeutics

Role Description

Reporting to the Director, Supply Chain, this role is expected to work closely within the Supply Chain team, as well as cross-functional groups such as Clinical Operations and Quality. This is a remote or hybrid position.

Responsibilities

• Supports the development and execution of Clinical Supply strategies for all 4DMT’s Phase 1/2/3 investigational drug products and ancillaries.
• Coordinate and track bulk drug orders to ensure adherence to pre-defined supply and resupply timelines.
• Monitor site inventory on a daily basis; coordinate and track drug shipments to ensure uninterrupted supply.
• Supports drug product inventory management and distribution in partnership with 4DMT’s clinical partners; evaluates drug utilization versus forecast considering country requirements and logistical timeline.
• Maintains study and depot-level accountability and reconciliation documentation to support regulatory compliance and study closeout.
• Tracks and resolves study and depot level temperature excursions. Provide routine reporting of drug wastage due to these excursions.
• Archives Proof of Delivery (POD) documentation.
• Maintain traceable documentation to support GXP activities.
• Archives documentation on Trial Master Files as required.

Qualifications

• Degree in biological or life sciences, pharmacy or medicine (or international equivalent).
• A minimum of 3 years in the pharmaceutical industry or relevant work experience and a minimum of 1 year in Clinical Supply Chain.
• Familiar in the daily management and operations of a Clinical Supply Chain inclusive of bulk management, distribution, and maintaining study blinds across multiple investigational products.
• Experienced with Interactive Response Technology - IRT systems for inventory management and resupply.
• Working knowledge of regulations relating to clinical labeling, packaging, and distribution activities; working knowledge of GMP/GCP/GLP regulations.

Skills

• Intermediate/Advanced knowledge of Microsoft Suites.
• Knowledge of Clinical Supply Management.
• Solid written and verbal communication skills.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent interpersonal and communication skills.
• Positive attitude with a strong desire for continuous learning.

Compensation

Hourly compensation range: $58.00 - 70.00

Equal Employment Opportunity

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.