Jobs at Arrowhead Pharmaceuticals

Manage global tax compliance, ASC 740 tax provision and disclosures, corporate income and indirect tax filings, tax audits, third‑party advisors, SOX internal controls, and cross‑functional tax planning and documentation.

Leads process engineering, technology transfer, process validation, documentation, troubleshooting, and process improvement teams supporting GMP oligonucleotide manufacturing. Oversees scale-up from development to internal manufacturing, ensures regulatory and change-control compliance, manages personnel and stakeholder communication, and supports validation, deviations, CAPAs, and manufacturing optimization. Provides technical mentorship, promotes safety, and ensures alignment with FDA, EMA, ICH, and applicable API manufacturing requirements.

Provide regulatory review and strategic guidance for promotional and medical communications across channels, lead MLR meetings, manage FDA OPDP/2253 submissions, monitor enforcement trends, support product launches, develop SOPs, mentor junior staff, and collaborate cross-functionally to ensure compliant promotional materials.

Leads a team of CMC analytical scientists supporting pharmaceutical drug substance and drug product development. Oversees analytical method development, validation, characterization, GMP testing, technical documentation, regulatory CMC submissions, and vendor/CDMO collaboration. Provides scientific direction, mentoring, workload prioritization, and cross-functional project leadership while ensuring compliance with cGMP and regulatory requirements.

Provides technical oversight and lifecycle management for externally manufactured drug substance programs. Reviews GMP batch documentation, trends process and quality data, leads deviation and root-cause investigations, supports process improvements, coordinates oligonucleotide manufacturing, and assists with technology transfer to contract manufacturers. The role also executes scale-up conjugations and bench-scale reactions while collaborating cross-functionally with process development, analytical, regulatory, quality, and manufacturing teams.

Drafts, edits, and standardizes GMP documentation for deviations, investigations, CAPAs, and change controls. Translates SME input into clear, compliant, inspection-ready QMS records aligned with data integrity, cGMP, and site procedures. Coordinates with cross-functional teams to improve approval quality, supports audits and inspections, and ensures investigations include appropriate evidence, root cause analysis, corrective actions, and effectiveness checks.

Leads technical transfer activities supporting GMP manufacturing readiness. Develops and maintains batch records, process documentation, methods, SOPs, and master data; coordinates cross-functional process transfer projects; manages timelines and milestones; reviews executed batch records; leads deviation investigations and CAPA activities; and drives documentation improvements. Requires occasional laboratory support and collaboration between process development and manufacturing teams.

Conduct analytical testing and process characterization for oligonucleotide synthesis and purification development. Perform HPLC, UV/Vis, LC/MS, mass spectrometry, and other analyses; interpret experimental data; troubleshoot and maintain equipment; document laboratory work; support technology transfers to manufacturing; coordinate materials; and communicate project progress. The role requires chemistry or biochemistry expertise, laboratory experience, familiarity with cGMP practices, and strong analytical and problem-solving skills.

The role involves antibody engineering, including designing mutant phage libraries, molecular cloning, purifying antibodies, and collaborating with teams to advance drug development.

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.

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%.

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.