Director, Clinical Supply Chain
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What you'll do
- Own end-to-end clinical supply chain strategy for active and upcoming trials
- Develop and maintain clinical drug supply forecasts and demand plans, translating protocol design, enrollment projections, and dosing regimens into packaging, labeling, and distribution plans.
- Select and manage clinical packaging, labeling, and distribution vendors, including oversight and performance management of CMOs/CPOs and specialty distribution/depot partners.
- Own Interactive Response Technology (IRT/IWRS) requirements, build, and testing in partnership with Clinical Operations, and serve as the clinical supply lead on IRT vendor management.
- Manage comparator and ancillary supply sourcing, including global sourcing strategies where applicable.
- Oversee cold chain and temperature-controlled logistics, expiry/re-test date management, and label reconciliation across depots and sites.
- Partner with CMC/Technical Operations to align clinical supply timelines with drug substance and drug product manufacturing schedules.
- Ensure compliance with GMP, GCP, and applicable import/export regulations across all clinical supply activities, including serialization and country-specific labeling requirements.
- Support regulatory submissions with clinical supply chain content (e.g., IMPD/IND sections, label text) in partnership with Regulatory Affairs and Quality.
- Manage clinical supply budget, purchase orders, and vendor invoicing in partnership with Finance.
- Build scalable clinical supply chain processes and systems as Frontier's clinical portfolio and trial complexity grow.
What they're looking for
- Bachelor's degree in a scientific, supply chain, or related field; advanced degree a plus.
- 8+ years (Director) or 10+ years (Sr. Director) of clinical supply chain experience in biotech or pharma, including oncology trial experience.
- Direct experience with IRT/IWRS systems, clinical packaging and labeling, and global clinical distribution.
- Working knowledge of GMP/GCP requirements as they apply to clinical supply.
- Experience managing CMO/CPO and distribution/depot vendor relationships.
- Strong cross-functional collaboration skills, particularly with CMC/Technical Operations, Clinical Operations, Quality, and Regulatory Affairs.
- Comfortable in a fast-paced, dynamic environment; a proactive, roll-up-your-sleeves mindset appropriate for a lean, growing organization.
- Legally authorized to work in the United States.
Nice to have
- Advanced degree
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Frontier is looking for a Director/Sr. Director, Clinical Supply Chain to build and lead clinical trial supply strategy across our growing clinical portfolio. This is a hands-on, high-visibility role responsible for ensuring investigational product is forecasted, packaged, labeled, and delivered to clinical sites on time and in compliance with GMP/GCP requirements, keeping pace with an evolving trial portfolio. Reporting to the Head of Technical Operations and CMC, this role will partner closely with CMC, Clinical Operations, Quality, and Regulatory Affairs to keep supply ahead of trial demand as Frontier's pipeline advances.
Requirements
What will you be doing?
• Own end-to-end clinical supply chain strategy for active and upcoming trials
• Develop and maintain clinical drug supply forecasts and demand plans, translating protocol design, enrollment projections, and dosing regimens into packaging, labeling, and distribution plans.
• Select and manage clinical packaging, labeling, and distribution vendors, including oversight and performance management of CMOs/CPOs and specialty distribution/depot partners.
• Own Interactive Response Technology (IRT/IWRS) requirements, build, and testing in partnership with Clinical Operations, and serve as the clinical supply lead on IRT vendor management.
• Manage comparator and ancillary supply sourcing, including global sourcing strategies where applicable.
• Oversee cold chain and temperature-controlled logistics, expiry/re-test date management, and label reconciliation across depots and sites.
• Partner with CMC/Technical Operations to align clinical supply timelines with drug substance and drug product manufacturing schedules.
• Ensure compliance with GMP, GCP, and applicable import/export regulations across all clinical supply activities, including serialization and country-specific labeling requirements.
• Support regulatory submissions with clinical supply chain content (e.g., IMPD/IND sections, label text) in partnership with Regulatory Affairs and Quality.
• Manage clinical supply budget, purchase orders, and vendor invoicing in partnership with Finance.
• Build scalable clinical supply chain processes and systems as Frontier's clinical portfolio and trial complexity grow.
What are we looking for?
• Bachelor's degree in a scientific, supply chain, or related field; advanced degree a plus.
• 8+ years (Director) or 10+ years (Sr. Director) of clinical supply chain experience in biotech or pharma, including oncology trial experience.
• Direct experience with IRT/IWRS systems, clinical packaging and labeling, and global clinical distribution.
• Working knowledge of GMP/GCP requirements as they apply to clinical supply.
• Experience managing CMO/CPO and distribution/depot vendor relationships.
• Strong cross-functional collaboration skills, particularly with CMC/Technical Operations, Clinical Operations, Quality, and Regulatory Affairs.
• Comfortable in a fast-paced, dynamic environment; a proactive, roll-up-your-sleeves mindset appropriate for a lean, growing organization.
• Legally authorized to work in the United States.
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Free Food & Snacks
- Wellness Resources
- Stock Option Plan
At Frontier, we strive to build a diverse and equitable workplace. The salary range for this role is $215,000 - $275,000 Compensation for the role will depend on a number of factors, including candidates' qualifications, skills, competencies and experience. Frontier offers a competitive total rewards package which includes healthcare coverage, 401k and a broad range of other benefits.
This compensation and benefits information is based on Frontier's knowledge as of the date of publication, and may be modified in the future.
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