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Clinical Supply Specialist (Contract)

4D Molecular Therapeutics

Role overview

Qualifications

  • Degree in biological or life sciences, pharmacy, or medicine (or international equivalent) with 3+ years in the pharmaceutical industry and at least 1 year in Clinical Supply Chain
  • Experience with Clinical Supply Chain operations including bulk management, distribution, and maintaining study blind across multiple investigational products
  • Experience with Interactive Response Technology (IRT) systems for inventory management and resupply
  • Working knowledge of GMP/GCP/GLP regulations and regulatory aspects of clinical labeling, packaging, and distribution

Responsibilities

  • Develop and execute Clinical Supply strategies for Phase 1–3 investigational products and ancillaries, collaborating with cross-functional teams
  • Coordinate and track bulk drug orders and monitor site inventory to ensure on-time supply and uninterrupted shipments
  • Manage drug product inventory and distribution with clinical partners, evaluating utilization versus forecast across countries and timelines
  • Maintain traceability and regulatory documentation (POD, GXP artifacts, Trial Master Files), archive records, and report temperature excursions and drug wastage

About the company

4D Molecular Therapeutics logo

4D Molecular Therapeutics

Biotechnology

4DMT is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine to treat large market and rare diseases. Our vector discovery platform Therapeutic Vector Evolution harnesses the power of directed evolution, a Nobel Prize-winning technology, with approximately one billion synthetic AAV capsid-derived sequences to invent customized and evolved vectors with improved therapeutic profiles compared to wild-type vectors. Our product design, development and manufacturing engine empowers us to efficiently create our valuable and diverse product pipeline. This combination of bold innovation and relentless execution gives 4DMT the capability to revolutionize genetic medicines and to strive for potential curative therapies. We have built a deep portfolio of genetic medicine product candidates, with five product candidates in clinical trials for seven patient populations. We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our 4 Guiding Principles drive the way we work together: - Dare to Cure - Break Boundaries - Beyond Yourself - Prepare & Executive Relentlessly Join us in creating the future of genetic medicine.

Company details

IndustryBiotechnology
Company size51 - 200

Links

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Job description

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

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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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