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.

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.

QUALIFICATIONS:

Education:

• Bachelor’s degree in supply chain or other disciplines with equivalent industry experience

Experience:

• 8+ years of experience in clinical or in combination with commercial supply chain management, with at least 3 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

Skills:

• 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.

Travel: <5%

Physical Requirements and Working Conditions:

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Base salary compensation range: $177,000 - 205,000

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.