Senior Clinical Drug Supply Manager
Amneal Pharmaceuticals
August 13, 2026
Remote friendly (Bridgewater, NJ)
United States
Operations
Responsibilities:
- Develop and maintain demand forecasts and study supply plans/timelines; lead supply strategy for multiple global complex trials (e.g., dose escalation, randomized arms, combination therapies).
- Coordinate global drug supply activities: inventory/storage management, depot stocking, re-supply, expiration management, IMP destruction, and IMP shipping conditions to ensure uninterrupted site availability.
- Coordinate packaging, labeling, kit design, and distribution of investigational product (IP), comparators, and ancillary supplies; monitor shelf-life/expiry for temperature-sensitive/high-value therapies; support relabeling, re-packaging, and returns/destruction.
- Maintain audit-ready documentation (packaging orders, shipping records, reconciliation reports) and prepare IND/CTA drug supply documentation.
- Partner with CROs/packagers/depots and internal stakeholders; oversee vendor performance and escalate issues; support site readiness.
- Track global shipments and resolve logistics issues (delays, temperature excursions, customs/import/export holds); maintain distribution records.
- Support IRT/IWRS configuration/maintenance, monitor inventory, trigger resupply, and support UAT/go-live readiness; reconcile inventory discrepancies.
- Ensure compliance with GCP/GMP/GDP/SOPs; support inspections/audits and deviation/CAPA activities; drive process improvement and forecasting/supply visibility.
- Manage clinical supply budgets and optimize inventory to minimize waste.
- Lead and mentor clinical drug supply professionals.
Qualifications:
- Bachelor’s degree (BA/BS) in Life Sciences, Pharmaceutical Sciences, Supply Chain, Logistics, or related field (Required).
- 8+ years in clinical trial supply/clinical operations/logistics/pharmaceutical supply chain; global clinical trial experience across multiple phases.
- Experience with IRT/IWRS and CTMS; experience with oncology trials and/or specialty pharma programs.
Skills/Knowledge (Required/Preferred):
- Clinical supply forecasting, packaging/labeling, distribution, and global import/export requirements.
- IRT/RTSM and supply optimization experience; knowledge of GCP/GMP/GDP.
- Strong organizational/project coordination, attention to detail, cross-functional/global communication, and proactive problem-solving.
- Proficiency in Microsoft Office (Excel, Word, Outlook); ERP and CTMS platform experience preferred.
Benefits/Compensation:
- Base salary: $170,000–$190,000/year; short-term incentive/bonus opportunity within first 12 months.
Education/Other:
- None beyond listed degree.
Application instructions:
- Not provided.
- Develop and maintain demand forecasts and study supply plans/timelines; lead supply strategy for multiple global complex trials (e.g., dose escalation, randomized arms, combination therapies).
- Coordinate global drug supply activities: inventory/storage management, depot stocking, re-supply, expiration management, IMP destruction, and IMP shipping conditions to ensure uninterrupted site availability.
- Coordinate packaging, labeling, kit design, and distribution of investigational product (IP), comparators, and ancillary supplies; monitor shelf-life/expiry for temperature-sensitive/high-value therapies; support relabeling, re-packaging, and returns/destruction.
- Maintain audit-ready documentation (packaging orders, shipping records, reconciliation reports) and prepare IND/CTA drug supply documentation.
- Partner with CROs/packagers/depots and internal stakeholders; oversee vendor performance and escalate issues; support site readiness.
- Track global shipments and resolve logistics issues (delays, temperature excursions, customs/import/export holds); maintain distribution records.
- Support IRT/IWRS configuration/maintenance, monitor inventory, trigger resupply, and support UAT/go-live readiness; reconcile inventory discrepancies.
- Ensure compliance with GCP/GMP/GDP/SOPs; support inspections/audits and deviation/CAPA activities; drive process improvement and forecasting/supply visibility.
- Manage clinical supply budgets and optimize inventory to minimize waste.
- Lead and mentor clinical drug supply professionals.
Qualifications:
- Bachelor’s degree (BA/BS) in Life Sciences, Pharmaceutical Sciences, Supply Chain, Logistics, or related field (Required).
- 8+ years in clinical trial supply/clinical operations/logistics/pharmaceutical supply chain; global clinical trial experience across multiple phases.
- Experience with IRT/IWRS and CTMS; experience with oncology trials and/or specialty pharma programs.
Skills/Knowledge (Required/Preferred):
- Clinical supply forecasting, packaging/labeling, distribution, and global import/export requirements.
- IRT/RTSM and supply optimization experience; knowledge of GCP/GMP/GDP.
- Strong organizational/project coordination, attention to detail, cross-functional/global communication, and proactive problem-solving.
- Proficiency in Microsoft Office (Excel, Word, Outlook); ERP and CTMS platform experience preferred.
Benefits/Compensation:
- Base salary: $170,000–$190,000/year; short-term incentive/bonus opportunity within first 12 months.
Education/Other:
- None beyond listed degree.
Application instructions:
- Not provided.