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.