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Associate Director, Clinical Supply Chain Management

1 hour, 57 minutes 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 5

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 and other stakeholders to define demand assumptions such as patient, site, country, and enrollment projections.
  • Collaborate with manufacturing teams to create drug product delivery schedules that align with demand.
  • Manage the 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, including distribution centers, packaging vendors, and couriers.
  • Develop IRT user requirement specifications and conduct user acceptance testing.
  • Monitor inventory levels across depots and clinical sites and coordinate resupply to prevent stockouts or overages.
  • Ensure compliant global distribution of investigational product, including adherence to country-specific regulations and customs requirements.
  • Lead and mentor clinical supply chain staff and serve as a cross-functional liaison across internal teams and external partners.

Requirements

  • Master’s degree or bachelor’s degree in Supply Chain Management, Logistics, Pharmaceutical Sciences, or a related field.
  • 12+ years of relevant supply chain management experience and 5+ years in a leadership role.
  • Certification in Supply Chain Management or Project Management is a plus.
  • Experience managing inventory and supply chains for complex global clinical trials using Microsoft Excel-based models and SaaS forecasting tools.
  • Operations experience in a biotech or pharmaceutical company; startup experience is 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 ICH guidelines, CFR, EMA GMP and GDP guidelines, and Good Manufacturing Practices (GMP).
  • Proven ability to manage multiple projects, identify and mitigate risks, and resolve issues with strong attention to detail.
  • 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% domestically and internationally, including at least two annual All Hands meetings.

Benefits

  • Fully remote work arrangement.
  • Market-competitive compensation, including a base salary of $170,000-$190,000 per year.
  • Performance bonus and equity grant opportunities.
  • Health, welfare, and retirement benefits.
  • Three weeks of PTO, two one-week company-wide shutdowns per year, and paid sick leave.
  • Professional development support and access to resources for growth.
  • 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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