Clinical Supply Specialist (Contract)

4D Molecular Therapeutics • Emeryville, CA

3d • Hybrid

About The Position

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

Requirements

• 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
• 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
• 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

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 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level