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Associate Director, Clinical Supply Chain Management

2 months, 1 week ago
United States
Full-time
Lead
Operations Manager
Project and Program Management
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 20

Description

  • Develop and implement clinical supply strategies to meet study timelines for complex multinational clinical programs.
  • Prepare demand forecasts using simulation and forecasting tools while accounting for trial design, enrollment, manufacturing availability, and regulatory requirements.
  • Partner with Clinical Operations, Manufacturing, and other stakeholders to define demand assumptions and delivery schedules.
  • Oversee procurement, packaging, labeling, distribution, and return of clinical trial materials in compliance with quality and regulatory standards.
  • Manage vendor relationships for outsourced supply chain services such as distribution centers, packaging vendors, and couriers.
  • Develop IRT user requirement specifications and conduct user acceptance testing.
  • Maintain inventory management systems and monitor depot and site inventory levels to prevent stockouts or overages.
  • Ensure compliant global distribution of investigational products, including country-specific regulations and customs requirements.
  • Lead supply chain risk assessments, identify disruptions, and implement mitigation actions.
  • Lead and mentor clinical supply chain staff while serving as a cross-functional liaison across internal teams and external partners.

Requirements

  • Bachelor’s or Master’s degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or a related field.
  • 12+ years of relevant supply chain management experience.
  • 5+ years of leadership experience.
  • Experience managing inventory and supply chain operations for complex global clinical trials.
  • Experience using Microsoft Excel-based models and SaaS forecasting tools.
  • Biotech or pharmaceutical operations experience; startup experience is a plus.
  • Third-party selection and management experience is required.
  • Significant experience with international clinical supply and knowledge of import/export requirements.
  • Working knowledge of ICH guidelines, CFR, and EMA GMP and GDP guidelines, with a solid understanding of GMP.
  • Experience developing and managing program budgets.
  • Strong knowledge of Microsoft Office, including Excel and PowerPoint, and Smartsheet.
  • Ability and willingness to travel up to 15%, including at least two annual All Hands meetings.
  • Certification in Supply Chain Management or Project Management is a plus.

Benefits

  • Anticipated salary range of $170,000 to $190,000 per year.
  • Market-competitive compensation and benefits package, including performance bonus and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, two one-week company-wide shutdowns per year, and dedicated paid sick leave.
  • Fully remote work arrangement.
  • Access to professional development resources and growth opportunities.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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