Manager, Clinical Supply Chain Management

 

About Apogee Therapeutics Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally. Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.” We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.  If this sounds like you, keep reading!

 

Role Summary

We are seeking a highly motivated and results-oriented Manager, Clinical Supply Chain. Management. In this position, you will be responsible for managing the end-to-end clinical supply chain on single or multiple clinical programs working closely with Clinical Operations, Regulatory Affairs, Quality, Development, Manufacturing, and the clinical supply chain team. This includes leading complex programs that will require multinational interactions, and ensuring changes in supply configuration, trial design, enrollment timeline, manufacturing availability, and regulatory requirements are considered.  In this role you will partner with Clinical Operations to monitor and review enrollment plans and actuals for use in developing the supply requirements plans.  Additionally, you will coordinate and lead supply activities with both internal and external partners and serve as a key point of contact with multiple functional areas. The position is fully remote and reports to a senior member of the Clinical Supply Chain team.

Key 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

Ideal Candidate

• S/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.
• Position requires up to 20% travel (domestic and international) including 2 times per year for All Hands meetings

The anticipated salary range for candidates for this role will be $140,000 to $150,000 per 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.

 

What We Offer

• 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
• 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

  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.   Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.   To review our privacy policy, click here

 

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