Clinical Supply Specialist (Contract)
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
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
GENERAL SUMMARY:
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 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:
Education and Experience:
- 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
Hourly compensation range: $58.00 - 70.00/hr