Sr. Clinical Supply Chain Manager

About this role

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 biologics (aflibercept and anti-VEGF-C) with a single 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 and the second indication is diabetic macular edema, which are both in Phase 3 development. 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.

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 Core Values drive the way we work together:

• Dare to Cure

• Break Boundaries

• Beyond Yourself

• Prepare & Execute Relentlessly

Join us in creating the future of genetic medicine.

GENERAL SUMMARY

The Sr. Clinical Supply Chain Manager is a senior, hands-on, study supply lead responsible for the strategy, start-up, execution, and lifecycle management of global clinical supplies, with primary emphasis on study start-up activities for complex programs. Working with a high degree of independence, this role serves as the sponsor-side clinical supply representative on cross-functional study teams and translates protocol, enrollment, country, manufacturing, release, and regulatory assumptions into an executable supply strategy. This role will also need to have an in-depth understanding of the required study start-up activities and can anticipate potential supply impacts.

The role is expected to lead multiple global study start-ups from protocol development through First Patient, First Visit (FPFV) readiness, establish scalable supply models, anticipate risks before they affect study milestones, and provide clear recommendations to senior stakeholders. The position partners closely with Clinical Operations, CMC/Manufacturing, Quality, Regulatory Affairs, Clinical Science, Finance, and external vendors and service providers.

The successful candidate operates as a study supply lead, not solely as a logistics coordinator. They can enter a complex Phase 3 start-up, quickly establish the assumptions and critical path, create an integrated plan, drive cross-functional decisions, and escalate early with practical options. They combine strategic planning with hands-on execution and can stabilize a study before transitioning routine operational management as appropriate.

MAJOR DUTIES & RESPONSIBILITIES:

Study Start-Up Leadership

• Own the clinical supply workstream for complex global study start-up, from protocol concept and country strategy through site activation and First Patient, First Visit (FPFV) readiness.

• Build and maintain integrated start-up plans with the team covering demand assumptions, manufacturing and release, packaging and labeling, IRT cross-configuration, depot activation, import/export readiness, site supply, comparator and ancillary sourcing, and contingency stock.

• Assess protocol design, treatment arms, randomization, visit schedules, titration or rescue requirements, enrollment ramps, screen failure, dropout, resupply logic, and geographic expansion for supply impact.

• Define supply readiness criteria, identify critical-path dependencies, challenge unrealistic assumptions, and drive decisions and escalations across study teams.

• Lead supply scenario planning for accelerated enrollment, manufacturing or release delay, expiry constraints, regulatory delay, country additions, protocol amendments, and other material changes.

Clinical Supply Strategy and Forecasting

• Develop and own end-to-end supply strategies for investigational product, comparator, diluent, ancillary materials, and other protocol-required supplies.

• Create demand forecasts and supply plans using enrollment, dosing, cohort, country, site, lead-time, expiry, and inventory assumptions; document assumptions and reconcile forecast changes.

• Optimize inventory and resupply parameters to protect patient continuity while minimizing waste, overage, expiry exposure, and avoidable manufacturing burden.

• Integrate drug product availability, packaging capacity, QA release, shelf life, stability projections, and regulatory constraints into study-level and portfolio plans.

IRT, Distribution, and Inventory Oversight

• Provide business ownership for clinical supply aspects of IRT design, including supply algorithms, depot and site resupply, inventory status, expiry controls, kit management, UAT, go-live readiness, and ongoing data review.

• Establish and oversee global depot and distribution strategies, including lane qualification, cold-chain requirements, import/export documentation, customs readiness, and country-specific requirements.

• Monitor inventory health, shipment…