4dmoleculartherapeutics

Sr. Clinical Supply Chain Manager

Emeryville, California. Posted 11 days ago

The role

The Sr. Clinical Supply Chain Manager is a senior study supply lead responsible for the strategy, start-up, execution, and lifecycle management of global clinical supplies. This role translates protocol and regulatory assumptions into executable supply strategies and leads multiple global study start-ups.

What you will do

  • Own the clinical supply workstream for complex global study start-up.
  • Build and maintain integrated start-up plans covering demand, manufacturing, and distribution.
  • Assess protocol design and its impact on supply.
  • Define supply readiness criteria and drive decisions across study teams.
  • Lead supply scenario planning for various material changes.
  • Develop and own end-to-end supply strategies for investigational products and ancillary materials.
  • Create demand forecasts and supply plans.
  • Optimize inventory and resupply parameters.
  • Provide business ownership for clinical supply aspects of IRT design.
  • Oversee global depot and distribution strategies.

Required qualifications

  • Bachelor's degree in supply chain, life sciences, pharmacy, or a related discipline
  • Minimum 8 years of progressive experience in clinical supply chain, clinical operations supply, or a closely related discipline within biotechnology or pharmaceuticals
  • Substantial sponsor-side experience and demonstrated ownership of end-to-end clinical supply activities
  • Proven experience leading at least one complex, global Phase 3 study start-up through supply readiness
  • Demonstrated expertise in demand forecasting, packaging and labeling, IRT supply design and UAT, global distribution, depot strategy, import/export, inventory and expiry management, accountability, re
  • Working knowledge of cGMP, GDP, GCP interfaces, FDA and EMA expectations, and international clinical supply requirements
  • Experience selecting and governing external partners, managing budgets and contracts, resolving complex deviations or supply disruptions, and presenting risk-based recommendations to senior stakeholde
  • Advanced project leadership, analytical, communication, negotiation, and problem-solving skills
  • Proficiency with IRT, demand-planning and inventory data, and Microsoft Excel and PowerPoint

Nice to have

  • Advanced degree or relevant professional certification
  • 4 years of experience working with IRT
  • Experience with multi-country, blinded, comparator-controlled, cold-chain, biologic, or advanced-therapy studies
  • Experience with GMO requirements and APAC, European, and other global markets
  • Experience creating dashboards or portfolio-level supply reporting

Before you apply

  • All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team.
  • No unsolicited resumes will be accepted.

About the company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed to provide multi-year sustained delivery of anti-VEGF biologics.

Sr. Clinical Supply Chain Manager at 4dmoleculartherapeutics | JobZoey