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July 4, 2026

Associate Medical Director / Medical Director

Senior • On-site

260,000 - 310,000 USD/yr

Los Angeles, CA

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing RNA interference (RNAi)-based therapies for genetically driven diseases.

The Associate Medical Director/Medical Director will report to the head of cardiometabolic clinical development and will be instrumental in bringing new RNAi therapies to patients. This individual will collaborate with scientific and clinical teams to advance drugs from late-stage clinical research through NDA filings, with an initial focus on siRNA programs targeting cardiac and metabolic indications including lipids and obesity.

This is a full-time onsite position based at the corporate headquarters in Pasadena, CA.

Responsibilities

  • Support the conceptualization, design, development, execution, and communication of clinical studies across therapeutic areas
  • Act as a medical lead within cross-functional teams including medical, scientific, clinical, safety, program management, and regulatory staff
  • Communicate protocols and study information with clinical site investigators and staff
  • Interpret clinical trial data and communicate results accurately
  • Provide ongoing clinical monitoring including eligibility assessment, toxicity management, and drug safety surveillance
  • Contribute to IRB submissions, protocols, study reports, publications, and regulatory submissions including NDA/MAA filings
  • Provide scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management teams
  • Identify key opinion leaders and participate in advisory board meetings
  • Deliver scientific presentations at advisory boards and scientific meetings
  • Identify and evaluate medical needs and new applications of RNA interference therapies
  • Monitor developments in RNA interference across industry and academia
  • Support licensing activities and partner relationships

Requirements

  • M.D. or MD/Ph.D. with research experience
  • Hands-on translational research experience in pharmaceutical, biotechnology, or academic environments
  • Understanding of the drug development process
  • Knowledge of Good Clinical Practices, FDA regulations, and regulatory requirements
  • Ability to evaluate expert scientific advice
  • Strong written and verbal scientific communication skills
  • Ability to work independently in a fast-paced team environment
  • Strong clinical, scientific, and technical skills
  • Strong interpersonal and collaboration skills
  • Sense of urgency with problem-solving initiative
  • Project management skills and results-oriented mindset

Preferred

  • Fellowship training in cardiology or endocrinology
  • Research focused on lipids or obesity

Benefits

  • Competitive salary and benefits package
  • California pay range: $260,000–$310,000 USD
  • Candidates must have valid authorization to work in the country where the role is located

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Los Angeles, CA

200,000 - 260,000 USD/yr

🏢 Summary: Corporate Counsel role focused on market access, pricing, reimbursement, trade, and distribution legal support for pharmaceutical products in U.S. and global markets. The position involves advising on government pricing programs, payer and PBM agreements, compliance, and commercialization strategies while collaborating across legal and commercial teams. Based in Pasadena, CA, this in-office role also includes contract negotiation, regulatory guidance, and risk mitigation responsibilities. 🗂️ Requirements: 3+ years experience in trade and distribution, government pricing, payer contracting, or related pharmaceutical legal practice, J.D. degree, Licensed to practice law in the U.S., Permitted to practice law in California, Active state bar membership in good standing, Knowledge of fraud and abuse laws related to payer and PBM agreements, Experience with pharmaceutical pricing, reimbursement, and market access issues, Knowledge of Medicaid Drug Rebate Program, 340B, and Federal Supply Schedule, Understanding of pharmaceutical sales and marketing regulatory frameworks, Strong legal communication and risk assessment skills, Ability to manage competing priorities in a fast-paced environment, Authorization to work in the country where the role is located 📃 Skills: RNAi, FDA, PBM, 340B, Medicaid, Medicare, MLR, Contracting, Reimbursement, Pricing, Compliance, Distribution, Regulatory 🏢 Description: Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company developing RNAi-based therapies for diseases with a genetic basis. The company focuses on innovative drugs targeting conditions involving overproduction of disease-related proteins, with programs in liver and lung diseases and a growing preclinical pipeline. The Corporate Counsel (Market Access and Pricing) will report to the Assistant General Counsel and provide strategic, business-focused legal and risk counseling related to pricing, reimbursement, market access, trade, and distribution activities for U.S. and global markets. The role involves close collaboration with legal, commercial, and contracts teams to support commercialization strategies and ensure compliance with healthcare laws and regulations. This role is based in Pasadena, California, with an expectation to be in office 5 days a week. Responsibilities - Provide strategic counsel on drug pricing, reimbursement, and market access issues - Serve as an enterprise expert on federal supply schedule contracting and federal/state pricing requirements - Advise on compliance with government price laws, including Medicaid Drug Rebate Program, Medicare Part D Manufacturer Discount Program, and 340B program requirements - Advise on arrangements and interactions with pharmacy benefit managers, health plans, employers, governments, and other payers - Provide legal guidance on trade and distribution strategies, patient support programs, state price reporting, rebate and discount arrangements, value-based agreements, and payer communications - Negotiate and draft agreements related to market access and pricing activities - Provide legal oversight for third-party contractors handling market access, invoicing, price reporting, and distribution services - Manage outside counsel regarding ex-US requirements - Serve as a secondary legal representative on the Medical Legal Regulatory (MLR) Review Committee - Support FDA promotional law matters, medical and marketing interactions, and healthcare compliance strategies - Engage with government or regulatory agencies regarding policy implications and legal perspectives - Prepare and deliver organizational training on contracting and risk mitigation Requirements - 3 years of experience involving trade and distribution, government pricing, payer contracting, or related fields in a law firm, pharmaceutical company, or medical device company - J.D. degree and license to practice law in the U.S. - Permission to practice law in California, including as Registered In-House Counsel - Active state bar membership in good standing - Deep knowledge of fraud and abuse laws related to payer and PBM agreements - Experience with competition, pricing, reimbursement, and market access issues in the pharmaceutical industry - Knowledge of government pricing programs including Medicaid Drug Rebate Program, 340B, and Federal Supply Schedule - Understanding of statutory and regulatory frameworks governing pharmaceutical sales and marketing - Strong oral and written communication skills - Strong analytical, strategic thinking, and time management abilities - Business acumen and ability to provide practical, risk-based legal advice - Conflict resolution and collaboration skills in a global environment Benefits - California pay range: $200,000—$260,000 USD - Competitive salary and benefits package - Opportunity to develop additional legal practice areas within a small legal department Candidates must have current, valid authorization to work in the country where this role is located.

Healthcare

Arrowhead Pharmaceuticals

Director, Regulatory Affairs (Labeling)

Senior

On-site

San Diego, CA

210,000 - 230,000 USD/yr

🏢 Summary: Senior Regulatory Affairs leadership role responsible for driving global labeling strategy and managing end-to-end regulatory labeling activities across development and post-approval phases. The position leads cross-functional collaboration, ensures compliance with global regulatory requirements, and oversees preparation, review, and maintenance of core and regional labeling documents. It also supports health authority interactions, policy development, and continuous improvement of labeling processes. 🗂️ Requirements: Bachelor's degree in life sciences, computer science, or related science discipline, Minimum 8+ years in biotech or pharmaceutical industry managing product labeling across at least two major geographic regions, Experience developing and maintaining global regulatory labeling throughout all development phases, Knowledge of FDA guidance documents and advertising promotion regulations, Experience negotiating with regulatory authorities and leading cross-functional discussions, Ability to review and ensure accuracy and compliance of regulatory labeling documents, Strong knowledge of MS Word formatting, PDF compliance, and validation tools, Valid work authorization in the country where the role is located 📃 Skills: Regulatory, Labeling, FDA, CCDS, USPI, SmPC, Veeva, RIM, AI, MSWord, PDF 🏢 Description: Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 Director of Regulatory Affairs is Arrowhead's Labeling lead, who drives cross-functional development and execution of global regulatory labeling strategy. This individual will manage regulatory labeling through all phases of development and post-approval (end-to-end) ensuring that the latest requirements and standards are met. The ideal candidate will have experience collaborating with product and clinical development, medical, market access, and commercial stakeholders to generate phase and time-appropriate target product profile and labeling drafts, has successfully negotiated with health authorities, and global regulatory experience. Responsibilities Collaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetings. Manage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Maintain expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles. Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities. Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents). Liaise with cross functional members and stakeholders to obtain input pertaining to labeling including resolution of key regulatory issues and labeling changes . Partner with Clinical Regulatory and cross-functional teams to support labeling supplements and updates, and health authority interactions related to labeling Ensure the dissemination of approved labeling documents and supporting documentation. Maintain controlled records for all labeling changes and communicate labeling updates to stakeholders at the time of implementation. Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise. Participate in any relevant continuous improvement efforts for the end-to-end labeling process. Monitor global regulatory environment and assess impact of changes on business and product labeling activities. Facilitate policy development and updates with internal stakeholders. Requirements Bachelor's degree in life sciences, computer science, or related science discipline Minimum 8+ in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas. Knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling Experience leading cross-functional meetings and facilitating strategic discussions, such as negotiating with internal stakeholders and regulatory authorities on complex labeling issues. Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistencies. Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools) Ability to maintain highest degree of professionalism, integrity and diplomacy Preferred Experience with regulatory information management systems (e.g., Veeva RIM, Registrations). Knowledgeable in emerging technologies, including AI applications in regulatory operations. Experience supporting global inspection readiness. California pay range $210,000—$230,000 USDArrowhead provides competitive salaries and an excellent benefit package. Candidates must have current, valid authorization to work in the country where this role is located. California Applicant Privacy Policy