Associate Director, Clinical Supply Chain Management

Job Description:

• Manage the end-to-end clinical supply chain for multiple clinical programs, ensuring the timely and efficient delivery of investigational products, comparators, and ancillary supplies to support global clinical studies.
• Collaborate closely with cross-functional teams including Clinical Operations and Development, Regulatory Affairs, Manufacturing, Quality, and external partners to manage supply planning, inventory control, distribution, and logistics in compliance with regulatory requirements and Good Manufacturing Practice (GMP) standards.
• Develop and implement clinical supply strategies to meet study timelines for complex programs that require multinational interactions by reviewing clinical trial synopsis’ and/or protocols to understand IMP supply and demand requirements.
• Prepare demand forecast(s) using simulation and/or forecasting tools, ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered.
• Partner with Clinical Operations and other stakeholders to determine demand assumptions, such as number of patients and clinical sites, countries/regions, enrollment rates, etc.
• Collaborate with manufacturing to develop drug product delivery schedules to meet demand.
• Optimize supply chain operations to minimize waste and ensure availability of investigational medicinal products (IMP) and materials while maintaining a low risk profile.
• Establish SOP’s and work instructions required to manage clinical supply.
• Oversee the procurement, packaging, labeling, distribution, and return of clinical trial materials, ensuring quality standards and regulatory compliance.
• Manage the label development process.
• Manage vendor relationships for outsourced supply chain services, including distribution centers, packaging vendors, and courier services.
• Develop IRT User Requirement Specifications and conduct User Acceptance Testing.
• Conduct supply chain risk assessments, proactively identifying and mitigating potential disruptions to supply continuity.
• Maintain inventory management systems to ensure accurate tracking and traceability of all clinical materials.
• Monitor inventory levels at depots and clinical sites through the life of a trial and coordinate resupply efforts to prevent stockouts or overages.
• Ensure timely and compliant distribution of IMP to clinical trial sites globally, adhering to country-specific regulations and customs requirements.
• Ensure compliance with all regulatory guidelines (e.g., FDA, EMA, ICH) and Good Distribution Practices (GDP) across all clinical supply chain activities.
• Support regulatory inspections and audits by maintaining thorough documentation of supply chain activities.
• Collaborate with Quality Assurance to manage deviations, CAPAs, and continuous improvement initiatives.
• Lead and mentor one or more clinical supply chain professionals, providing direction, training, and development opportunities.
• Serve as a key point of contact with multiple functional areas and act as a liaison between internal departments and external partners to ensure alignment on clinical supply chain goals and timelines.
• Participate in cross-functional project teams to drive supply chain efficiencies and resolve challenges as they arise.

Requirements:

• S/M.S. degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or related field with 12+ years of relevant experience in supply chain management and 5+ years in a leadership role. Certification in Supply Chain Management or Project Management a plus
• Experience with inventory and supply chain management for complex global clinical trials using Microsoft Excel based models and SaaS forecasting tools
• Operations experience in a biotech or pharmaceutical company, start-up experience a plus
• Third-party selection and management experience is required
• Knowledge of import/export requirements and significant experience with international clinical supply
• Working knowledge of the International Conference on Harmonization (ICH) guidelines, the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines, and a solid understanding of Good Manufacturing Practices (GMP)
• Proven ability to manage multiple projects, proactively identify and mitigate risks, and resolve issues using strong attention to detail and problem-solving skills
• Experience developing and managing program budgets
• Ability to adapt to a fast-paced, dynamic work environment and navigate through ambiguity
• Strong knowledge of Microsoft Office, including Excel and PowerPoint, and Smart Sheet
• Excellent communication and influencing skills, strong collaboration skills
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless.
• Ability and willingness to travel up to 15% (domestic and internationally) including a minimum of 2 times per year for All Hands meetings.

Benefits:

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development
• Apogee offers regular all team, in-person meetings to build relationships and problem solve

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