Manager, Clinical Supply Chain Management

Summary

Join Apogee Therapeutics as their Manager, Clinical Supply Chain Management! This fully remote position offers the chance to manage the end-to-end clinical supply chain across multiple clinical programs. You will collaborate with various departments, including Clinical Operations, Regulatory Affairs, and Manufacturing, to ensure efficient supply and demand planning. The role involves leading complex programs, managing international interactions, and developing supply strategies. You will also be responsible for monitoring inventory, coordinating distribution, and developing SOPs. This position requires a strong background in supply chain management within the biotech/pharmaceutical industry and experience with global clinical trials.

Requirements

• S/M.S. Science or Engineering, or related fields with 5+ years of relevant experience in supply chain management
• 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
• 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

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; 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 and report 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

Preferred Qualifications

• Certification in Supply Chain Management or Project Management
• Start-up experience
• Third-party management experience

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient 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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• 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