Apogee Therapeutics - Associate Director, Clinical Supply Chain Management
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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 • 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.
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.
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 • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
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