Jobs at Arrowhead Pharmaceuticals

Supports environmental, health, and safety programs at a biotechnology research facility. Responsibilities include inspections, audits, incident investigations, regulatory reporting, risk assessments, hazardous chemical and biological waste management, laboratory safety training, contractor monitoring, and EHS support for facility and process projects. The role promotes compliance, injury prevention, corrective actions, and continuous improvement of the site safety culture.

Supports global regulatory projects for RNAi-based therapeutics, including preparation and submission of INDs, CTAs, marketing applications, briefing documents, and progress reports. Develops regulatory strategies, coordinates health authority interactions, manages submission plans and timelines, reviews technical documentation, monitors regulatory intelligence, and advises cross-functional development teams on compliance and risk mitigation.

Leads the Quality Control laboratory organization across analytical, microbial, stability, reference standards, and product testing for oligonucleotide and biologics platforms. Oversees QC strategy, GMP compliance, inspection readiness, PAI preparation, method validation, PPQ support, technical transfers, budgets, facilities, staffing, and cross-functional collaboration with Manufacturing, MSAT, Regulatory, Analytical Development, and Supply Chain. Represents QC during regulatory inspections and manages multiple QC managers and supervisors.

Leads corporate FP&A, including annual planning, long-range planning, forecasting, executive and Board reporting, variance analysis, scenario modeling, and G&A finance partnering. Supports partnership finance, financial decision-making, and continuous improvement of FP&A systems and processes, including Anaplan. Collaborates with executive leadership, Accounting, IT, and business functions across the organization.

Supports Quality Assurance document control and training compliance in a GxP-regulated biopharmaceutical environment. Responsibilities include maintaining controlled documents, quality and training records, approval workflows, audits, inspections, document retention, training materials, completion monitoring, compliance reporting, and new-hire training activities. The role ensures documentation accuracy, traceability, completeness, and audit readiness while coordinating with internal stakeholders.

Owns payer and PBM accounts, supports National Account Directors, and presents formulary, policy, claims, and utilization-management insights. Tracks coverage and access barriers across Commercial, Medicare Part D, and Medicaid plans; analyzes pharmacy, HUB, and specialty pharmacy data; communicates payer intelligence to field teams and leadership; and collaborates with Market Access, Trade, Distribution, Patient Services, Sales, Analytics, and Finance while ensuring regulatory compliance.

Ensures suppliers, contract manufacturers, laboratories, and material suppliers meet pharmaceutical quality and regulatory requirements. Manages supplier corrective actions, change notifications, quality agreements, KPIs, procedural documents, regulatory inspection support, and cross-functional quality assessments. Maintains compliance with cGMP, 21 CFR, USP, EP, ICH, FDA, EMA, GxP, and GDP requirements while supporting continuous supplier improvement and commercialization activities.

Contribute to preclinical histology by planning and executing tissue collection, processing, embedding, sectioning, and staining (H&E, special stains, IHC/IF). Maintain audit-ready records in LIMS/ELN, perform microscopy and imaging, support method validation (e.g., RNAscope), and operate/maintain histology instrumentation while communicating results to study teams.

Develop and manage strategic relationships with Optum and Emisar stakeholders to secure formulary access for Arrowhead therapies. The role leads payer account planning, contracting negotiations, performance evaluation, market access strategy, and cross-functional collaboration across Market Access, Sales, Medical Affairs, Analytics, Finance, and Compliance. Responsibilities include communicating clinical and economic value, monitoring payer trends and policies, aligning affiliated delivery networks, presenting insights internally, and ensuring regulatory compliance. This field-based position requires travel up to 50%.

Develops and manages strategic relationships with government and Medicare payer accounts to secure formulary and coverage access for Arrowhead’s therapies. Communicates clinical and economic value, leads account planning and contract negotiations, monitors payer trends and sales implications, and collaborates with Sales, Medical Affairs, Analytics, Finance, and Compliance. Requires extensive pharmaceutical market access experience, government payer relationships, cross-functional influence, and travel up to 50%.

Develop and manage strategic payer relationships with Zinc GPO, CVS Caremark, and affiliated commercial and Medicare stakeholders to secure formulary access. Lead account planning, contracting negotiations, performance evaluation, and payer engagement for Arrowhead’s commercial portfolio. Communicate clinical and economic value, monitor payer policies and market intelligence, collaborate cross-functionally, and support launch and post-launch access strategies. This field-based role requires travel up to 50%.

Provides administrative and operational support for clinical trial planning and execution. Maintains study trackers, contracts, budgets, essential documents, training records, and TMF files; supports regulatory submissions, trial registration, vendor coordination, meetings, document quality control, and study system setup. The role requires strong organization, communication, attention to detail, knowledge of ICH-GCP and GDP, and proficiency with Veeva eTMF and Microsoft Office tools.

Reviews and approves clinical trial site and vendor budgets, contracts, and payments for global Phase I-IV studies. Performs fair market value benchmarking, reconciliations, compliance checks, and site payment monitoring. Maintains trial documentation and site lists, identifies cost-saving opportunities, tracks site performance, resolves discrepancies, and provides financial guidance to internal and external stakeholders.

Lead partner-facing end-to-end supply chain for out-licensed RNAi therapeutics, translating contracts into operational plans, managing demand & supply planning, coordinating clinical/commercial cold-chain logistics, ensuring regulatory and quality alignment, reporting KPIs, and mitigating partner-specific supply risks across global markets.

Prepares SEC filings, technical accounting analyses, monthly and quarterly close activities, reconciliations, disclosure checklists, audit materials, and SOX-compliant controls. Partners with Investor Relations, Legal, Treasury, Tax, IT, and auditors to ensure accurate and timely financial reporting. Supports accounting policy improvements, reporting calendars, variance analysis, and technical areas including leases, equity, debt, and EPS disclosures.

Provides quality assurance support for outsourced pharmaceutical development, manufacturing, and testing programs. Reviews and approves vendor documentation, supports quality events and non-conformances, performs lot disposition, generates compliance certificates and vendor metrics, and manages regulated documents in an electronic document management system. The role collaborates with internal teams and contract organizations across commercial, clinical, and preclinical programs while ensuring compliance with applicable quality agreements, GMP, GCP, GLP, ICH, and FDA guidance.

Supports quality assurance for preclinical, clinical, and commercial drug development programs. Reviews and approves analytical data, reports, batch records, raw material documentation, labels, and controlled forms; performs lot disposition, room releases, and floor QA. Assists with investigations, deviations, documentation control, EDMS workflows, training, and GMP compliance activities while collaborating with manufacturing, QC, analytical development, and external partners.

The Senior Scientist I, DMPK will lead preclinical DMPK studies, manage data analysis, and ensure regulatory compliance for RNAi therapeutics.

The Group Manager leads cross-functional CMC teams overseeing drug development projects, manages external relationships with partners, and ensures project alignment with timelines and quality standards.

The Director of IT Infrastructure leads the strategy and operations of the company's IT infrastructure, managing cloud platforms, team development, budget, compliance, and system reliability.