Clinical Supply Specialist (Contract)

United States·EmeryvilleRemotemid

OtherClinical

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Quick Summary

Overview

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.

Key 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…

Requirements Summary

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.

Technical Tools

gcp

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

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