Remote Manager, Clinical Supply Chain Management

Summary

Join Apogee Therapeutics as a Manager, Clinical Supply Chain Management and be responsible for managing the end-to-end clinical supply chain on single or multiple clinical programs. This role involves leading complex programs that require multinational interactions, ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered.

Requirements

• BS/M.S. Science or Engineering, or related fields with 5+ years of relevant experience in supply chain management, 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 management experience is preferred
• 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 resolve issues using strong attention to detail and problem-solving skills
• 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

Responsibilities

• Review clinical trial synopsis and/or protocols to understand IMP supply and demand requirements
• Partner with Clinical Operations to determine demand assumptions, such as number of patients, number of sites, number of countries, enrollment rates, etc
• Create, review, and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs using simulation and/or forecasting tools
• Collaborate with Technical Operations to develop drug product delivery schedules to meet demand requirements
• Develop packaging and supply strategies to meet clinical study needs, maximize supply efficiency, and minimize waste while maintaining a low risk profile
• Manage the label development process
• Develop requests for proposals for labeling, packaging, storage, and distribution, and analyze quotes from prospective providers and make recommendations to management
• Represent Apogee with selected external providers to develop project requirements and provide project management oversight during execution
• Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
• Coordinate US and international distribution and logistics for clinical programs
• Develop SOP’s and work instructions required to manage clinical supply
• Participate in the development of IRT user requirement specifications and acceptance testing

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Flexible PTO
• Two, one-week company-wide shutdowns each year