Senior Manager Clinical Supply Chain at Arcutis Biotherapeutics

, , United States -

Full Time

Start Date

Immediate

Expiry Date

23 Jun, 26

Salary

160000.0

Posted On

25 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

End-to-End Supply Chain Management, Demand Forecasting, Supply Planning, Packaging And Labeling Strategy, Distribution Logistics, Returns Management, Reconciliation, Study Closeout, Inventory Strategy, Risk Mitigation, Vendor Management, IRT Strategy, GMP/ICH Compliance, Stakeholder Management, Root-Cause Analysis, Budget Planning

Industry

Biotechnology Research

Description

The Senior Clinical Supply Chain Manager leads end-to-end clinical investigational product (IP) supply strategy and execution across a portfolio of clinical trials, ensuring uninterrupted, compliant, and cost-effective supply to global sites and depots. This role leads cross-study demand and supply planning, sets inventory and buffer strategies to minimize scrap/expiry risk, drives operational excellence across packaging/labeling/distribution/returns, and serves as a key strategic partner to Clinical Operations, Regulatory Affairs, Quality, CMC, and external vendors (CMOs, depots, CROs, and IRT providers). The Senior Manager navigates ambiguity, proactively identifies risks, and influences stakeholders to deliver program milestones from study start through study closure. Roles & Responsibilities * Lead end-to-end clinical supply planning and execution for a portfolio of studies, including demand forecasting, supply planning, packaging/labeling strategy, distribution, returns, reconciliation, disposition/destruction, and study closeout. * Own cross-functional supply strategy and timelines to support key milestones (e.g., FPI, LPLV/LPLD), ensuring supplies are not on the critical path;developscenario plans and contingency approaches. * Establish and govern inventory strategies (buffer levels, resupply triggers, pooling, expiry/shelf-life controls) to balance service level with scrap risk;monitorand manage shelf life and expiry proactively. * Lead product forecast conversations with study teams;maintainand refine enrollment/forecast models and assumptions based on the latest protocol amendments, enrollment performance, and site-level demand signals. * Serve asescalationpoint for business-critical supply risksimpactingtimelines; drive root-cause analysis, mitigation planning (alternate suppliers, labeling contingencies, accelerated packaging), and stakeholder alignment. * Drive execution with external partners (CMOs, clinical packagers, depots, couriers/logisticsproviders, CROs) including oversight of performance, issue resolution, and continuous improvement. * Lead IRT strategy and execution (as needed): set and approve key parameters, oversee integration requirements, coordinate UAT (including review of test orders), and ensure ongoing alignment between supply plans and IRT settings. * Ensureaccurateinventory visibility across bulk and packaged materials using inventory systems (e.g., IRT, vendor portals, ERP modules or equivalent); perform and approve inventory reconciliations and data quality checks. * Oversee clinical supply documentation (supply plans, transfer/receipt records, reconciliation reports, DR/IDR records,CoDs) and ensure inspection-ready compliance for audits and health authority inspections. * Partner with Regulatory Affairs and Quality to ensure labeling, clinical text, and distribution activities meet regional requirements and applicable GMP/ICH expectations. * Lead or contribute to SOP development and updates; implement standard work and best practices across studies to improve cycle time, compliance, and cost. * Provide executive-ready status reporting anddashboarding;support budget planning, invoice review, cost tracking, and cost optimization initiatives. * Mentor andprovidefunctional guidance to supply chain staff. Required Qualifications * Bachelor’s degree in Life Sciences, Supply Chain, Pharmacy, Business, or related area (Master’sdegree preferred). * 7+ years of experience in biotechnology/pharmaceutical and/or cell & gene therapy environments with direct clinical supply chain ownership across multi-site and multi-country trials. * Demonstratedexpertisein demand forecasting, supply planning, packaging and labeling operations, distributionlogistics, returns/reconciliation, and destruction management. * Proven experience managing external vendors (CMOs, clinical packaging sites, depots, CROs, couriers/logisticsproviders, and IRT vendors) and resolving operational conflicts. * Working knowledge of GMP/ICH expectations as they relate to clinical supplies, documentation practices, andinspectionreadiness. * Advancedproficiencywith Excel and strong comfort with clinical supply systems (IRT), inventory tracking tools, and business productivity software (Word, PowerPoint, etc.). * Excellent communication, stakeholder management, and risk-based decision-making skills in fast-paced, ambiguous environments. Preferred Qualifications * Master’s degree related to Pharmaceutical Sciences, Operations, or Manufacturing Engineering. * Experience managing topical, solid oral dose, and biologic drug clinical trials. * Experience with multiple IRT platforms and clinicallogisticsvendor portals. * Project management certification (PMP). * Experience with global supply chain operations including import/export, customs, and import permits. * This role is remote and travel is required based on project need. Why Join Us? Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exiting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission! This job description has been designed to indicate the general nature and level of work performed by employees in this position. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. Arcutis is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. California Employee/Applicant Privacy Notice [https://www.arcutis.com/wp-content/uploads/Employee-Applicant-Privacy-Notice.pdf]

Responsibilities

The Senior Manager leads the end-to-end clinical investigational product supply strategy and execution across a portfolio of trials, focusing on uninterrupted, compliant, and cost-effective global supply. Key duties include leading cross-study planning, setting inventory strategies, driving operational excellence in logistics, and serving as a strategic partner to various internal and external stakeholders.