Arrowhead Pharmaceuticals jobs

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Associate Medical Director will report to Arrowhead's Medical Director and play a key role in advancing innovative RNA interference-based therapies to patients. This individual will work collaboratively with Arrowhead's scientific and clinical teams, guiding drug candidates from discovery through early-stage clinical development. The initial focus will be on si RNA programs targeting metabolic, renal, neuro, and complement-mediated diseases. While experience in these areas is preferred, it is not required. In this role, the Associate Medical Director will take hands-on responsibility for designing and managing translational studies and early-phase clinical trials, assessing the efficacy, safety, clinical pharmacology, and pharmacokinetics of product candidates across various disease areas. This is a unique opportunity to contribute to the development of cutting-edge therapeutics and make a meaningful impact on patient care. This is a fulltime, onsite position based from Arrowhead's Corporate Headquarters in Pasadena, CA. Responsibilities Support the design, development, execution and communication of translational and clinical studies across a wide variety of therapeutic areas; Act as a medical lead in a cross functional team that includes medical scientific, clinical, safety, program and regulatory staff Effectively communicate protocols and other relevant information with clinical site investigators and staff Interpret clinical trial data and communicate results clearly and accurately Act as medical monitor for clinical studies and provide clinical input to safety assessments Contribute to documents, including IRB submissions, protocols, CSRs, publications and regulatory submissions Identify key opinion leaders and participate in clinical advisory board meetings Make scientific presentations at advisory boards, key scientific meetings and external committee meetings Identify and evaluate medical need and clinical path for new applications of RNA interference for the treatment of disease Collaborate with scientific staff to drive new drug candidates through preclinical development Monitor and understand new developments in RNA interference in industry and academia Support in-licensing and out-licensing activities and partner relationships Requirements: M.D., Ph.D. or M.D. combined with research experience Hands-on translational research experience within a pharmaceutical or biotechnology company or in an academic setting Demonstrated understanding of the drug development process and a strong desire to contribute to the development of meaningful therapeutics Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements Ability to effectively evaluate outside expert advice Ability to clearly elucidate complex scientific and medical concepts via written and oral communication Working independently and effectively in a fast-paced, team-based environment Strong clinical/scientific/technical skills Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions Project management skills and focus on delivery of results Preferred: Fellowship training California pay range $240,000-$290,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity. Responsibilities * Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS). * Collect site metrics for selection of investigator site audits while analyzing and reporting trends. * Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions. * Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing. * Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards. * Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs. * Provide QA support for clinical study programs with GCP compliance, as needed. * Assist during health authority inspections, including document management and logistical coordination. * Support and contribute to risk management analysis efforts associated with GCP functions. * Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level. * Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. * Facilitate ongoing quality improvement through communication of audit results and CAPAs * Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches). * Keep up to date with all related quality legislation and compliance issues. Requirements: * Bachelor's degree in a science discipline is required. * 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience. * 2 years of relevant experience in GxP function providing Quality and Compliance oversight. * Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA) Preferred: * Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines. * Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva). * Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness. Responsibilities Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses Assist in generation, tracking, monitoring, and reporting of key quality metrics Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams Support health authority inspections Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings) Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations. Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs) Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures Work with Vendor Management Teams on identifying and mitigating any compliance issues Oversee contract auditors and others perform audits on behalf of Arrowhead Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories Other duties consistent with the position as assigned from time to time Requirements: Bachelor's degree in a science discipline is required. 5 years of relevant experience in GxP auditing and compliance Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial Requires travel to other Arrowhead locations as well as domestic and international travel California pay range $105,000-$125,000 USDCalifornia pay range $105,000-$125,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This role provides clinical pharmacology and pharmacometrics leadership for assigned development programs and may be based in San Diego, CA or Madison, WI. The position is responsible for contributing to clinical trial design, authoring key protocol and regulatory sections, and performing hands-on PK/PD analyses to guide dose selection and program strategy. It oversees the preparation and authorization of PK analysis reports, CSR content, and clinical pharmacology components of global regulatory submissions Responsibilities Provide Clinical Pharmacology and pharmacometrics leadership for designated programs, contribute to design of clinical trial protocols and relevant sections in Investigational Brochure (IB), conduct hands-on analysis of clinical or translational PKPD data, support dosing strategies and clinical pharmacology planning. Authorize clinical PK analysis reports and relevant sections in the Clinical Study Report (CSR). Provide high quality documentation of clinical pharmacology analysis compatible with global regulatory submission requirements. Authorize clinical pharmacology modules of CTD to support global filings of marketing application. Provide timely communication of analysis results and interpretation with drug development teams. Maintain a current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics Requirements PhD or PharmD in the field of pharmacokinetics, pharmacology or pharmaceutical science, 3 years of pharmaceutical industry experience in clinical-stage drug development. Good understanding of FDA/EMA/ICH guidance related to clinical pharmacology Established experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin with familiarity of authorizing PK study report. Proficiency in NONMEM and skill of population PKPD modeling is essential. Preferred: PBPK/PD modeling California pay range $120,000-$170,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking a highly motivated and skilled Molecular Biologist to join our dynamic research team in Discovery Chemistry,. The successful candidate will play a key role in antibody engineering to support platform development and drug delivery initiatives. This position requires extensive hands-on experience in phage display, antibody engineering, and antibody characterization, supported by a strong foundation in molecular biology. Responsibilities Design and construct mutant phage libraries for antibody affinity maturation or humanization. Perform molecular cloning, mutagenesis, antibody gene assembly, and expression vector design. Express and purify recombinant antibodies using bacterial and mammalian expression systems. Perform binding, specific and in vitro functional assays. Collaborate with cross-functional project teams to advance lead antibodies through drug development stages. Maintain accurate documentation and present findings at internal meetings. Requirements Ph.D. in Biology, Biochemistry, Molecular Biology, or a related field. Hands-on experience with phage display technology for antibody engineering. Proficiency in molecular cloning, PCR, and mutagenesis. Experience with antibody expression and purification using E. coli, HEK293, and CHO systems. Strong analytical and problem-solving skills, with the ability to troubleshoot experiments independently. Excellent record-keeping, communication, and collaboration skills. Proven ability to adapt to fast pace and evolving research priorities Track record of scientific productivity, including peer-reviewed publications, conference presentations, or patents Additional experience in molecular biology and/or antibody discovery is highly desirable Preferred Industry or postdoc experience California pay range $120,000-$150,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking a statistical programmer to join our growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. This is an exciting opportunity for a candidate trained in statistical methods and analysis who has some or limited prior experience working as a statistical programmer. They will initially contribute their expertise in the area of statistical programming, with a goal to develop as a clinical trial statistician. Responsibilities Develop targeted, study-specific SDTM and ADaM dataset checks Perform independent QC, from raw data to ADaM, of primary and key secondary endpoints Deliver programming results for ad-hoc analysis requests Collaborate with data management and their programming team to ensure appropriate data collection and reporting Participate in study team meeting and support statistician operational activities Assist in efforts to identify, develop, and implement departmental standards, applications, processes and training Requirements: Master's degree in Biostatistics/Statistics Basic understanding of clinical trials Working knowledge of SAS, including complex data manipulation and basic analysis procedures; or certifications for SAS programming Excellent verbal and written communication skills Preferred: Familiarity with CDISC standards, derivation of SDTM and ADaM specifications Simulations and sample size calculation Proficiency in R CRO experience California pay range $90,000-$135,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

The Project Manager is an integral part of several Product Teams developing novel RNAi therapeutics for diseases with high unmet need. The Project Manager will work under the Senior Director, Program Management to define and monitor timelines and deliverables. The successful Project Manager will have excellent knowledge in Smartsheet and other program planning and visualization software, good communication skills and enthusiasm for defining and monitoring program plans and milestones at Arrowhead Pharmaceuticals. This role is based in Pasadena, California, with an expectation to be in office 5 days a week. Responsibilities * Drive cross-functional collaboration to develop and manage integrated late-phase program plans and timelines * Facilitate and document meetings, capturing and tracking key decisions, action items, and follow-ups * Prepare and deliver presentations, reports, and events to align and engage stakeholders * Develop scenario planning models and visualizations to support strategic and operational decisions * Coordinate across Product and Work Package Teams with diverse technical and functional backgrounds * Standardize and communicate program timelines across teams and the broader portfolio * Manage resources and budgets using Smartsheet or equivalent planning and visualization tools * Monitor progress, track deliverables, and proactively identify and escalate risks to Program Leadership * Maintain dashboards, portfolio updates, and enterprise-level progress reports * Support special projects as needed including workshop facilitation to vendor assessments * Collaborate within a matrixed organization to integrate program timelines, resolve bottlenecks, and ensure cross-program alignment Requirements: * Bachelor's degree in a business-related or life sciences field * Strong understanding of the life sciences industry * 5 years of project planning or coordination experience in biotech, pharmaceuticals, or medical devices * Strong foundation in program and project management principles * Proven ability to understand complex interdependencies and maintain attention to detail * Demonstrated experience leading or coordinating cross-functional teams * Excellent communication, influencing, stakeholder management, and decision-making skills * Highly motivated team player with a proactive, collaborative approach * Thrives in a dynamic, growing biotech or early commercial-stage environment

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking a stellar biostatistician to join our rapidly growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. As an internal expert in biostatistics, you will provide technical leadership and biostatistical input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Commercial, Program Management and others. Responsibilities Provide sound statistical and operational input, including study and program design, writing of the protocol sections, statistical analysis plans (SAP), clinical study reports (CSR), regulatory documents or scientific publications Partner with cross functional teams to provide strategic biostatistics input to support entire drug development process; ensure statistical integrity of all key deliverables Provide statistically sound scientific methodology for study design and data analysis input to meet project objectives in accordance to regulatory guidance and industry standards Collaborate with the programming and data management functions to ensure appropriate data collection and reporting Provide leadership in evaluating alternative or innovative methods of study design and analysis Assist in efforts to identify, develop and implement departmental standards, applications, processes and training Oversees statistical and programming deliverables by CROs Assist in identifying consultants and the selection of service providers Requirements: PhD in Biostatistics/Statistics 5 years of relevant experience in pharmaceutical or biotechnology drug development Understanding and experience with various aspects of a clinical development life-cycle, leading up to regulatory submission and post-approval activities Experience interacting with and overseeing biometrics services of CRO vendors Proficiency in the use of statistical software including SAS and R at minimum; familiarity with East and Sportfire Excellent verbal and written communication skills Knowledge of pharmaceutical clinical development processes and ability to effectively apply technical principles and methods to clinical drug development Effective in communication and team collaboration, influencing across different functional lines Knowledge of cross-functional department functions/roles within a drug development company Preferred: Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications California pay range $145,000-$190,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Manager, Artwork & Labeling is a detail-oriented and results-driven individual with a strong understanding of graphic design, pharmaceutical packaging regulations, GMP standards and workload management. This person is responsible for the creation, management, and implementation of commercial product labelling artwork. This position liaises and promotes exchanges in Global Operations, as well as with Regulatory Affairs, Quality, Supply Chain Planning, Marketing and Global Affiliates to ensure labelling change requests comply with company standards and are implemented in accordance with regulations and production schedules. Responsibilities Align artwork process strategies with broader Supply Chain, Regulatory, Quality, and Commercial objectives. Establish and maintain global governance frameworks, including SOPs, KPIs, change controls, and audit readiness protocols. Define and implement artwork workflows, documentation controls, and system interactions with appropriate stakeholders to ensure process consistency, quality, and traceability. Collaborate with Packaging and Device Engineering on product label/artwork development. Manage mock-up and artwork requests for labeling components, from development through review and approval to production implementation. Collaborate with Regulatory Affairs to create mock-ups supporting regulatory submissions and licensing activities, ensuring project timelines and milestones are met. Prepare error-free mock-ups and artwork using graphic design software and tools, interfacing with other functions within Arrowhead as well as printing/packaging vendors. Arrowhead point of contact for artwork vendors. Coordinate with external vendors, Procurement, and Supply Chain to ensure timely production. Optimize production processes for maximum efficiency, quality, and on-time delivery. Research and assess global labeling regulations and guidance documents, assisting in the development of procedures, guidelines, and maintenance systems for labeling development, approval, and control, while maintaining documentation and logs both in hardcopy and electronically. Oversee global artwork change control processes and validation protocols. Other duties as assigned Requirements Bachelor's Degree in Graphic Design or a related field. 5 years of professional design experience. Proficiency in problem-solving, communication, technical writing, and organization. Knowledge of software programs such as Adobe InDesign, Illustrator, Acrobat, Word, Excel, PowerPoint, and Outlook. Strong understanding of regulatory compliance requirements (e.g., GMP, CCDS, HA submissions) and global artwork-related standards and best practices. Experience in pharmaceuticals, packaging, and workflow. Preferred: Regulatory certifications (e.g., RAC) or equivalent professional credentials Wisconsin pay range $90,000-$115,000 USDCalifornia pay range $105,000-$125,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position We are seeking a highly motivated and skilled Molecular Biologist to join our dynamic research team in Discovery Chemistry. The successful candidate will play a key role in antibody discovery to support platform development and drug delivery initiatives. This position requires extensive hands-on experience in phage display, mammalian cell culture, and antibody production, supported by a strong foundation in molecular biology. Responsibilities Design, construct, and screen phage display libraries to identify lead antibodies. Perform molecular cloning, antibody gene assembly, and expression vector design. Express and purify recombinant antibodies using bacterial and mammalian expression systems. Characterize lead antibodies using binding assays (ELISA, SPR, BLI) and functional assays. Collaborate with cross-functional project teams to advance lead antibodies through drug development stages. Maintain accurate documentation and present findings at internal meetings. Requirements Ph.D. in Biology, Biochemistry, Molecular Biology, or a related field. Hands-on experience with phage display technology for antibody discovery. Proficiency in molecular cloning, PCR, and gel electrophoresis. Experience with antibody expression and purification using E. coli, HEK293, and CHO systems. Strong analytical and problem-solving skills, with the ability to troubleshoot experiments independently. Excellent record-keeping, communication, and collaboration skills. Proven ability to adapt to fast pace and evolving research priorities Track record of scientific productivity, including peer-reviewed publications, conference presentations, or patents Preferred Industry or postdoc experience California pay range $120,000-$150,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness. Responsibilities Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses Assist in generation, tracking, monitoring, and reporting of key quality metrics Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams Support health authority inspections Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings) Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations. Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs) Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures Work with Vendor Management Teams on identifying and mitigating any compliance issues Oversee contract auditors and others perform audits on behalf of Arrowhead Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories Other duties consistent with the position as assigned from time to time Requirements: Bachelor's degree in a science discipline is required. 5 years of relevant experience in GxP auditing and compliance Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial Requires travel to other Arrowhead locations as well as domestic and international travel California pay range $105,000-$125,000 USDCalifornia pay range $105,000-$125,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This is a global regulatory lead position responsible for leading a late-stage cardio-metabolic program, supporting multiple early phase global regulatory projects, and ensuring compliance with all relevant regulatory requirements and guidelines. This position will report to the Executive Director, Regulatory Affairs and collaborate with regulatory and other departments to ensure alignment and consistency in regulatory strategies and submissions. Responsibilities Lead the preparation and submission of regulatory filings (e.g., NDA, MAA, supplements, variations, IND, CTA, annual reports/progress reports, briefing documents, etc.) Prepare and coordinate Health Authority interactions Manage regional regulatory affiliates (and consultants) in preparation and submission of global marketing authorization applications. Responsible for the creation and implementation of submission project plans, content plans, and responsibility matrices to ensure consistency and completeness to standards for all regulatory submissions. Work with other regulatory leads to monitor and coordinate timelines of key program activities and the tracking of submission deliverables to maintain target submission dates. Assess and communicate regulatory requirements to ensure all development activities are conducted in compliance with applicable regulations and guidelines Ensure timely and accurate communications of regulatory updates and decisions to internal stakeholders. Provide regulatory support and guidance to various departments, programs, and teams with a strong emphasis on frequent interactions with technical teams Review technical documentation to ensure regulatory compliance and conformance with existing regulatory applications and approvals Research and analyze regulatory information and maintain current regulatory knowledge Ensures day-to-day regulatory requirements are met for their assigned programs and manager (i.e., archiving, submissions) Liaises with CRO(s) for submissions and ensures accuracy Requirements: Education equivalent to a BS or MS, plus 8 years of hands-on regulatory experience, or Education equivalent to a higher degree (PharmD or PhD), plus 6 years of hands-on regulatory experience, Experience with international regulatory submissions. Experience using Veeva RIM and SmartSheets Knowledgeable in ICH and FDA guidelines relevant to clinical aspects of product development. Ability to manage complex projects and timelines in a collaborative matrix team environment. Ability to communicate effectively (verbal and written) to multiple levels in the organization with strong negotiation skills. Ability to manage and execute on multiple projects ranging from complex to highly detailed administrative tasks Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors. Demonstrated ability to excel in smaller entrepreneurial organizations. Writing de-novo regulatory documents (eg, Cover letters, meeting requests, briefing books etc.) Experience in review of ICFs, Phase 1-4 clinical protocols, IBs, etc. to ensure they meet regulatory requirements and agreements Preferred: Led or experienced in market application filing (BLA/NDA or supplements/variation with clinical data) Led a health authority interaction (meeting or primary contact for IND/CTAs) Preparing/Writing de-novo regulatory meeting requests/ briefing books California pay range $180,000-$215,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity. Responsibilities Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS). Collect site metrics for selection of investigator site audits while analyzing and reporting trends. Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions. Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing. Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards. Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs. Provide QA support for clinical study programs with GCP compliance, as needed. Assist during health authority inspections, including document management and logistical coordination. Support and contribute to risk management analysis efforts associated with GCP functions. Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level. Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. Facilitate ongoing quality improvement through communication of audit results and CAPAs Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches). Keep up to date with all related quality legislation and compliance issues. Requirements: Bachelor's degree in a science discipline is required. 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience. 2 years of relevant experience in GxP function providing Quality and Compliance oversight. Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA) Preferred: Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines. Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva). Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial. California pay range $80,000-$95,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

We are seeking a statistical programmer to join our growing biometrics team to support clinical studies across Arrowhead's expanding portfolio. This is an exciting opportunity for a candidate trained in statistical methods and analysis who has some or limited prior experience working as a statistical programmer. They will initially contribute their expertise in the area of statistical programming, with a goal to develop as a clinical trial statistician. Responsibilities * Develop targeted, study-specific SDTM and ADaM dataset checks * Perform independent QC, from raw data to ADaM, of primary and key secondary endpoints * Deliver programming results for ad-hoc analysis requests * Collaborate with data management and their programming team to ensure appropriate data collection and reporting * Participate in study team meeting and support statistician operational activities * Assist in efforts to identify, develop, and implement departmental standards, applications, processes and training Requirements: * Master's degree in biostatistics/statistics/public health or similar field * Basic understanding of clinical trials * Working knowledge of SAS, including complex data manipulation and basic analysis procedures; or certifications for SAS programming * Excellent verbal and written communication skills Preferred: * Familiarity with CDISC standards, derivation of SDTM and ADaM specifications * Simulations and sample size calculation * Proficiency in R * CRO experience

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness. Responsibilities Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses Assist in generation, tracking, monitoring, and reporting of key quality metrics Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams Support health authority inspections Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings) Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations. Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs) Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures Work with Vendor Management Teams on identifying and mitigating any compliance issues Oversee contract auditors and others perform audits on behalf of Arrowhead Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories Other duties consistent with the position as assigned from time to time Requirements: Bachelor's degree in a science discipline is required. 5 years of relevant experience in GxP auditing and compliance Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial Requires travel to other Arrowhead locations as well as domestic and international travel California pay range $105,000-$125,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position This role provides clinical pharmacology and pharmacometrics leadership for assigned development programs and may be based in San Diego, CA or Madison, WI. The position is responsible for contributing to clinical trial design, authoring key protocol and regulatory sections, and performing hands-on PK/PD analyses to guide dose selection and program strategy. It oversees the preparation and authorization of PK analysis reports, CSR content, and clinical pharmacology components of global regulatory submissions Responsibilities Provide Clinical Pharmacology and pharmacometrics leadership for designated programs, contribute to design of clinical trial protocols and relevant sections in Investigational Brochure (IB), conduct hands-on analysis of clinical or translational PKPD data, support dosing strategies and clinical pharmacology planning. Authorize clinical PK analysis reports and relevant sections in the Clinical Study Report (CSR). Provide high quality documentation of clinical pharmacology analysis compatible with global regulatory submission requirements. Authorize clinical pharmacology modules of CTD to support global filings of marketing application. Provide timely communication of analysis results and interpretation with drug development teams. Maintain a current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics Requirements PhD or PharmD in the field of pharmacokinetics, pharmacology or pharmaceutical science, 3 years of pharmaceutical industry experience in clinical-stage drug development. Good understanding of FDA/EMA/ICH guidance related to clinical pharmacology Established experience in clinical NCA PK analysis and data reporting using Phoenix WinNonlin with familiarity of authorizing PK study report. Proficiency in NONMEM and skill of population PKPD modeling is essential. Preferred: PBPK/PD modeling California pay range $120,000-$170,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

The Associate Medical Director will report to Arrowhead's Medical Director and play a key role in advancing innovative RNA interference-based therapies to patients. This individual will work collaboratively with Arrowhead's scientific and clinical teams, guiding drug candidates from discovery through early-stage clinical development. The initial focus will be on si RNA programs targeting metabolic, renal, neuro, and complement-mediated diseases. While experience in these areas is preferred, it is not required. In this role, the Associate Medical Director will take hands-on responsibility for designing and managing translational studies and early-phase clinical trials, assessing the efficacy, safety, clinical pharmacology, and pharmacokinetics of product candidates across various disease areas. This is a unique opportunity to contribute to the development of cutting-edge therapeutics and make a meaningful impact on patient care. This is a fulltime, onsite position based from Arrowhead's Corporate Headquarters in Pasadena, CA. Responsibilities * Support the design, development, execution and communication of translational and clinical studies across a wide variety of therapeutic areas; * Act as a medical lead in a cross functional team that includes medical scientific, clinical, safety, program and regulatory staff * Effectively communicate protocols and other relevant information with clinical site investigators and staff * Interpret clinical trial data and communicate results clearly and accurately * Act as medical monitor for clinical studies and provide clinical input to safety assessments * Contribute to documents, including IRB submissions, protocols, CSRs, publications and regulatory submissions * Identify key opinion leaders and participate in clinical advisory board meetings * Make scientific presentations at advisory boards, key scientific meetings and external committee meetings * Identify and evaluate medical need and clinical path for new applications of RNA interference for the treatment of disease * Collaborate with scientific staff to drive new drug candidates through preclinical development * Monitor and understand new developments in RNA interference in industry and academia * Support in-licensing and out-licensing activities and partner relationships Requirements: * M.D., Ph.D. or M.D. combined with research experience * Hands-on translational research experience within a pharmaceutical or biotechnology company or in an academic setting * Demonstrated understanding of the drug development process and a strong desire to contribute to the development of meaningful therapeutics * Knowledge of Good Clinical Practices, FDA regulations and guidelines and applicable regulatory requirements * Ability to effectively evaluate outside expert advice * Ability to clearly elucidate complex scientific and medical concepts via written and oral communication * Working independently and effectively in a fast-paced, team-based environment * Strong clinical/scientific/technical skills * Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings * Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions * Project management skills and focus on delivery of results Preferred: * Fellowship training

This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness. Responsibilities * Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses * Assist in generation, tracking, monitoring, and reporting of key quality metrics * Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams * Support health authority inspections * Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings) * Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations. * Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs) * Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures * Work with Vendor Management Teams on identifying and mitigating any compliance issues * Oversee contract auditors and others perform audits on behalf of Arrowhead * Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories * Other duties consistent with the position as assigned from time to time Requirements: * Bachelor's degree in a science discipline is required. * 5 years of relevant experience in GxP auditing and compliance * Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines * Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience * Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial * Requires travel to other Arrowhead locations as well as domestic and international travel

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Project Manager is an integral part of several Product Teams developing novel RNAi therapeutics for diseases with high unmet need. The Project Manager will work under the Senior Director, Program Management to define and monitor timelines and deliverables. The successful Project Manager will have excellent knowledge in Smartsheet and other program planning and visualization software, good communication skills and enthusiasm for defining and monitoring program plans and milestones at Arrowhead Pharmaceuticals. This role is based in Pasadena, California, with an expectation to be in office 5 days a week. Responsibilities Drive cross-functional collaboration to develop and manage integrated late-phase program plans and timelines Facilitate and document meetings, capturing and tracking key decisions, action items, and follow-ups Prepare and deliver presentations, reports, and events to align and engage stakeholders Develop scenario planning models and visualizations to support strategic and operational decisions Coordinate across Product and Work Package Teams with diverse technical and functional backgrounds Standardize and communicate program timelines across teams and the broader portfolio Manage resources and budgets using Smartsheet or equivalent planning and visualization tools Monitor progress, track deliverables, and proactively identify and escalate risks to Program Leadership Maintain dashboards, portfolio updates, and enterprise-level progress reports Support special projects as needed including workshop facilitation to vendor assessments Collaborate within a matrixed organization to integrate program timelines, resolve bottlenecks, and ensure cross-program alignment Requirements: Bachelor's degree in a business-related or life sciences field Strong understanding of the life sciences industry 5 years of project planning or coordination experience in biotech, pharmaceuticals, or medical devices Strong foundation in program and project management principles Proven ability to understand complex interdependencies and maintain attention to detail Demonstrated experience leading or coordinating cross-functional teams Excellent communication, influencing, stakeholder management, and decision-making skills Highly motivated team player with a proactive, collaborative approach Thrives in a dynamic, growing biotech or early commercial-stage environment California pay range $110,000-$125,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy