Original listing text, shown exactly as published by the company.
Key Responsibilities
- Strategic Supply Chain Planning:
- 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.
- Clinical Supply Management:
- 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.
- Inventory & Distribution Oversight:
- 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.
- Regulatory Compliance & Quality Assurance:
- 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.
- Leadership & Cross-functional Collaboration:
- 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.
Ideal Candidate
- 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
The anticipated salary range for candidates for this role will be $170,000-$190,000/ year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
