Arcutis Biotherapeutics Inc

The Senior Manager, GxP IT Systems is responsible for the end-to-end lifecycle management and system ownership of Arcutis’ GxP IT systems. This role ensures governance and compliance, drives strategic initiatives, and ensures robust vendor and supplier management. Through cross-functional leadership, the Senior Manager partners with Business Process Owners, Quality, R&D, and other functions to deliver effective implementation, change management, operational excellence and inspection readiness of GxP IT systems. Critically, this role ensures adherence to regulatory requirements and internal SOPs for computerized systems.  Roles & Responsibilities Ensure compliance with Arcutis’ GxP SOPs and global regulationsOversee Computer System Validation (CSV) activities, including protocol development (IQ/OQ/PQ), risk assessments, and validation execution & documentation.Ensure robust change control, including ownership and management of GxP IT system change controls,...

The Therapeutic Sales Specialist (TSS) will play a critical role in the successful launch of Arcutis Biotherapeutics and its products. The TSS will be responsible for launching, promoting, and driving demand for Arcutis’ newly branded dermatology products in targeted specialty physician offices within the geography. The territory will be Cincinnati, OH . ROLES AND RESPONSIBILITIES Engage targeted dermatologists within assigned geography through regular in-person or virtual interactions to deliver scientific and clinically focused communicationsJoin an inaugural sales team to build and represent a new company and dermatology portfolio of productsStrategically create and maintain a territory business plan to ensure optimal account coverage and impact to achieve or exceed given territory and national sales objectives and goalsDevelop, maintain, and leverage a high level of product and disease state knowledge to promote the appropriate use of Arcutis products to key customersOrganize...

The Senior Manager, External Manufacturing will play a pivotal role in overseeing activities related to the production and supply of clinical and commercial drug products. This role spans from late-stage clinical development through scale-up and commercial manufacturing at contract manufacturing organizations (CMOs).  The ideal candidate will thrive in a fast-paced, collaborative environment, effectively manage ambiguity, and consistently drive results to meet key program milestones.   Roles & Responsibilities The Senior Manager of External Manufacturing will be responsible for the following key activities, including but not limited to: Program Management: Lead and manage external manufacturing programs with assigned CMOs. Responsibilities include developing and executing production plans, overseeing manufacturing operations, managing budgets, and ensuring on-time in-full delivery of program objectives. Cross-Functional Coordination: Collaborate effectively with...

The Senior Manager, Drug Product Development is a key member of the Manufacturing and Process Technology Team. To be successful in this role, the candidate should be able to work collaboratively in a fast-paced environment, navigate ambiguities, and drive results forward. This position will report to the Senior Director of Process Technologies and Manufacturing, and will serve as a business partner to other parts of organizations. Roles & Responsibilities Lead formulation, Device, and Drug Product deliverables to support pre-clinical, clinical/pivotal studies leading to IND, BLA/MAA and commercial launchEvaluate molecules for CQAs by the means of accelerated conditions and stress exposures, characterizing molecule variants and degradantsPlan, design and execute univariate/multivariate formulation and DP process characterization/validation studies with external testing sites, and drive timely execution with quality oversightGuide CRO in analytical testing with...

The Patient Access Manager (PAM) – Northeast , 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. The PAM will work with their leadership, Marketing, Medical, Compliance, and other colleagues to identify, design, revise, and roll out patient access materials as needed or improve existing materials. T his will be a remote position located in the East Region, and the candidate would ideally be in or near Boston, MA.   Roles & Responsibilities Execute Arcutis patient support programs,...

We’re seeking a Senior   Director of Sourcing & Procurement to lead the development and execution of our company-wide sourcing and procurement strategy. This role will report to the CFO and will be responsible for building scalable, compliant, and value-driven sourcing and procurement policies and processes that support our G&A, commercial, clinical, and manufacturing operations. They will work closely with internal and external stakeholders to achieve Company timelines and objectives — enabling the company and its employees to operate efficiently, responsibly, and strategically as we continue to grow. Roles & Responsibilities Develop and lead a company-wide program for sourcing & procurement, purchasing, negotiation, and vendor selection, including frameworks for vendor evaluation, engagement, and RFP ownership.Develop and manage sourcing plans for major spend areas, including, but not limited to, contract manufacturing, clinical operations, professional...

The Medical Science Liaison (MSL), Gulf Coast will represent the Medical Affairs organization to provide field scientific expertise to healthcare professionals (HCPs) and healthcare organizations (HCOs) in compliance with all policies, regulations, and guidelines. A successful candidate is responsible for providing fair balanced, objective, scientific information and appropriate product education to HCPs and HCOs for all Arcutis marketed and investigational products and therapeutic areas.  She/he must be recognized as having expert knowledge in Arcutis’ products and specified therapeutic areas by opinion leaders (OLs) and HCPs, and also will serve as a product/therapeutic area expert to internal business partners, ensuring scientific and training requirements are addressed adequately. The MSL is responsible for building relationships with recognized OLs, researchers, and institutions in the specified therapeutic area, with the ability to identify and address scientific...

The  Director of FP&A  reports to the Executive Director of Finance & Investor Relations and will be instrumental in building Arcutis’s decision support capability to enable efficient operations and effective capital allocation across the enterprise. The Director of FP&A will act as the Finance lead for the Clinical Development and Technical Operations functions at Arcutis and also lead consolidation and corporate finance efforts.   Roles & Responsibilities Collaborate cross-functionally to generate an annual budget and quarterly forecasts that ensure the Company’s operational focus and internal investment support achievement of key corporate priorities in a capital-efficient mannerAnalyze financial results on a monthly and quarterly basis, in partnership with functional leadership and Accounting team, to provide actionable insights on Arcutis’s ongoing businessDrive strategic planning as part of the annual long-range plan (LRP) exercise to enable investment...

The Director of Medicaid Accounts plays a critical leadership role in supporting the Sr. Director of Government Accounts in developing and executing Arcutis’ Medicaid payer strategy.  This position oversees key relationships with select Medicaid payer entities- including State and other Medicaid-aligned organizations – and is responsible for implementing the strategies, priorities and initiatives and direction set by the Sr. Director. The Director partners closely with cross-functional teams to operationalize State/Regional access strategies, enhance formulary positioning, support contract efforts and ensure alignment across the organization. Key Responsibilities:        Strategic Leadership & Account Oversight Serve as the primary executive point of contact for assigned Medicaid accounts, including select State Medicaid programs and other Medicaid-aligned entitiesDevelop and execute sophisticated, long-range account strategies that optimize access, reimbursement...

The  Senior Manager Quality Control , under the direction of the Director, will be responsible for planning, implementing and managing initiatives for Arcutis and will proactively oversee the Quality Control program for compliance with ICH/FDA/EMA Guidelines.  They will work closely with internal and external team members to meet Company timelines and objectives for Arcutis drug products, as well as preparation of CMC sections for regulatory submissions and responsible for participating in and supporting novel drug development projects. Roles & Responsibilities Manage the QC testing and release process for commercial topical products, ensuring timely lot disposition.Review and approve batch records, Certificates of Analysis (CoA), analytical test results, and stability data to ensure compliance with regulatory and product specifications.Coordinate with QA, Manufacturing, and Regulatory Affairs to resolve deviations, Out-of-Specification (OOS) results, and...