Arcutis Biotherapeutics

Role 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. - 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; develop scenario 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; monitor and manage shelf life and expiry proactively. - Lead product forecast conversations with study teams; maintain and refine enrollment/forecast models and assumptions based on the latest protocol amendments, enrollment performance, and site-level demand signals. - Serve as escalation point for business-critical supply risks impacting timelines; 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/logistics providers, 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. - Ensure accurate inventory 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 and dashboarding; support budget planning, invoice review, cost tracking, and cost optimization initiatives. - Mentor and provide functional guidance to supply chain staff. Qualifications - Bachelor’s degree in Life Sciences, Supply Chain, Pharmacy, Business, or related area (Master’s degree 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. - Demonstrated expertise in demand forecasting, supply planning, packaging and labeling operations, distribution logistics, returns/reconciliation, and destruction management. - Proven experience managing external vendors (CMOs, clinical packaging sites, depots, CROs, couriers/logistics providers, and IRT vendors) and resolving operational conflicts. - Working knowledge of GMP/ICH expectations as they relate to clinical supplies, documentation practices, and inspection readiness. - Advanced proficiency with 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 clinical logistics vendor portals. - Project management certification (PMP). - Experience with global supply chain operations including import/export, customs, and import permits. Benefits - This role is remote and travel is required based on project need. Company Description 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 exciting 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!

Role Description The Patient Access Manager (PAM) – Southwest, will be responsible for supporting and maintaining patient support services that maximize access to our product for patients to whom it has been prescribed. The PAM will execute pre-defined strategies to address patient access needs and support the identification of access barriers through this work. The PAM will also play a customer-facing role and work closely with our Directors of National Accounts (DNAs) and the field sales team to support the needs of healthcare providers and patients as it relates to the post-prescription access to ZORYVE. This will be a remote position located ideally in Phoenix, AZ or Denver, CO. Responsibilities - Execute Arcutis patient support programs, after the prescription has been written. - Help identify and provide information to resolve issues with payers and/or the pharmacy. - Liaise with medical offices and targeted pharmacies to educate and train on ZORYVE, ZORYVE Direct, and answer questions as appropriate. - Review and provide oversight of the patient prescription journey. - Serve as the primary point of contact for field sales regarding patient access questions/issues. - Report weekly changes in patient status, overall trends, successes, or roadblocks; suggest and execute appropriate, compliant action in response. - Monitor status of the prescription drug coverage process by partnering with pharmacies to triage, troubleshoot and resolve issues. - Abide by reasonable and lawful healthcare provider confidentiality and safety requirements. - Engage with Market Access team and Regional Sales Directors (RSDs) to ensure accurate communication on the status of the patient journey. - Willingness and ability to travel domestically (up to 50% travel, depending on location). - Manage virtual interactions with healthcare providers, pharmacies, and internal cross-functional partners. - Partner with Arcutis Safety and Pharmacovigilance to report adverse events and product complaints. - Become familiar with and abide by Arcutis’ policies and standard operating procedures. - Build internal, cross-functional relationships with Arcutis’ business units as needed. - Collaborate on the development and maintenance of PAM training content. - Build external relationships with pharmacies, patients, healthcare providers, medical office staff, and caregivers. - Other related functions or duties as assigned by Arcutis. Qualifications - Bachelor’s degree or equivalent experience in the healthcare field required; advanced degree preferred. - 3-5 years of healthcare or pharmaceutical experience; 1-2 years of field sales, field reimbursement management, and customer-facing experience. Requirements - Strong track record of success in the pharmaceutical industry; experience in product support and pharmacy benefits. - Robust knowledge of pharmacy access dynamics. - Ability to manage a case-load independently. - Ability to exercise good judgment and demonstrate successful working relationships with patients, healthcare providers, third-party vendors, and other stakeholders. - Experience working closely with field organizations to support healthcare providers and their patients. - Self-starter who can thrive in a competitive and fast-paced environment. - Keeps current and develops deeper and broader experience in own functional area. - Open to and actively solicits feedback on performance and skill development needs. - Demonstrates appreciation for diversity of perspectives and approaches among peers. - Understanding of U.S. biopharmaceutical Regulatory/Legal review process and Compliance landscape. - Collaboration & Teamwork. - Exceptional communication skills, with the ability to communicate effectively with diverse internal and external customers. Benefits - Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases. - Focus on filling the innovation gap in medical dermatology drug development. - Collaborative and passionate work environment.