Associate Director, Clinical Supply

4D Molecular Therapeutics•Emeryville, CA

13d•$177,000 - $205,000

About The Position

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: The Associate Director, Clinical Supply is responsible for projecting, planning, executing, and overseeing all supply chain activities related to clinical trial materials. This includes managing the procurement, production, packaging, labeling, distribution, and inventory of clinical trial materials to meet company goals within the defined timelines. This role ensures that clinical supplies, including investigational product, comparators, auxiliary IMPs, and supplies, are delivered on time, within budget, and in compliance with regulatory requirements. This role involves close collaboration with various departments, including Clinical Operations, Clinical Science, Quality Assurance, Regulatory Affairs, Manufacturing, and external vendors. Effective communication with stakeholders at all levels is required to provide regular updates on supply chain status and address any concerns. Serve as the primary point of contact for clinical supply-related inquiries and issues.

Requirements

Bachelor’s degree in supply chain or other disciplines with equivalent industry experience
9+ years of experience in clinical or in combination with commercial supply chain management, with at least 4 years in a senior or managerial role.
In-depth knowledge of clinical trial processes, GMP, GCP, and regulatory requirements
Proven experience in managing complex global supply chains for clinical trials (including Europe, APAC and South America)
Proven experience with high-complexity Phase 3 trials
Strong project management skills, with the ability to lead cross-functional teams and manage multiple priorities.
Excellent negotiation, communication, and interpersonal skills.
Proficiency in supply chain management software and tools.
Strong analytical and problem-solving abilities.
Ability to work in a fast-paced, dynamic environment and adapt to changing priorities.

Responsibilities

Supply Planning and Management: Develop and implement clinical supply strategies to support global clinical trials
Lead Phase 1 to 3 clinical trial materials planning and execution. Participate in cross-functional discussions early in the study design phase to ensure that material lead-time is properly built in for overall program timeline.
This includes Investigational Products (IP), diluent, comparator drugs, ancillary supplies, or any other clinical materials required and identified by each project team
Create detailed supply plans based on trial requirements, enrollment forecasts, and study timelines
Oversee material requirements for domestic and international study execution. Ensure procurement, production, packaging, labeling, and distribution of clinical trial materials are done per applicable local and international guidance
Inventory Control and Distribution: Manage inventory levels to ensure sufficient supply of clinical trial materials while minimizing waste.
Review of clinical supply requests, placing ancillary supply orders, and communicating IP demands
Coordinate the distribution of clinical supplies to CMO and study sites, ensuring timely delivery and adherence to protocols.
Monitor and track shipment status, resolving any issues that arise during transit.
Vendor Management.
Identify, select, and manage relationships with suppliers, manufacturers, and logistics providers including CMOs and CROs.
Plan and coordinate clinical supply activities including labeling, packaging, distribution of clinical trial supplies, randomization, and drug accountability systems control.
Negotiate contracts and service agreements with vendors to ensure cost-effective and high-quality supply chain operations.
Project Management: Participate in supply chain business process development project.
Drive continuous operational performance improvement efforts.
Ensure compliance with Good Manufacturing Practices and applicable state and federal regulatory authorities.
Others Generate and maintain various clinical supply inventory reports.
Ensure process execution is conducted per internal policy and procedures
Identify opportunities for process improvements and implement best practices in clinical supply chain management.
Perform other duties as assigned.