Senior Medical Scientist

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing 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. The company focuses on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins involved in disease. Arrowhead’s RNAi technologies enable addressing conditions across virtually any therapeutic area, including disease targets not otherwise addressable by small molecules and biologics. The company leads in bringing RNAi therapies to diseases outside the liver, with a clinical pipeline targeting the liver and lung, and a robust preclinical pipeline.

About the role

The Senior Medical Scientist, Drug Safety will provide operational and scientific support in managing the development, implementation, and oversight of Arrowhead investigational products. This includes supporting safety governance and surveillance procedures, safety reporting processes, advanced safety analytics, expedited and periodic aggregate reports, and ensuring compliance with internal standard operating procedures, FDA, and global safety reporting requirements. The role involves trend recognition, signal detection, and vendor oversight to ensure high-quality safety data collection, review, and analysis. This position collaborates with Drug Safety Operations, Safety Scientists, medical monitors, clinical operations, QA, Data Management, and regulatory colleagues to support clinical development programs and post-marketed products. This role is based onsite 5 days a week at Arrowhead's Research & Development site in San Diego, CA.

Responsibilities

• Review potential safety observations, safety signals, and contribute to the Safety Review Committee and Safety Governance process through the preparation and presentation of safety data.
• Prepare and assess safety data for ongoing periodic, aggregate safety data reviews, and provide recommendations for review and approval by the Executive Safety Committee.
• Prepare periodic aggregate safety reports including PSUR, DSUR, FDA IND Annual Report, etc.
• Perform routine signal detection, identify, and evaluate safety signals.
• Stay up to date on relevant regulations associated with safety activities.
• Develop and update Safety Surveillance Plans for assigned products.
• Support the preparation and maintenance of safety sections of Clinical Protocols, Clinical Study Reports, Company Core Data Sheet, Investigators Brochure, and Risk Management Plan.
• Assist in quality assurance activities, including deviation reports.
• Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure an effective reconciliation process.
• Assist with preparation for regulatory inspections, including compiling material relating to safety/pharmacovigilance reports and activities.
• Support activities associated with launching a filing for the BLA/NDA or global marketing.

Medical Review Responsibilities

• Perform Medical Review on SAE/SUSAR if applicable.
• Conduct active case follow-up, including written and verbal follow-up with clinical operations, clinical investigators, and sites if applicable.

Requirements

• MD or DO Degree.
• 8 years in the pharmaceutical industry or CRO.
• 5 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience.
• Experience in Signal Detection and Safety Data Analytics.
• Strong safety science experience to utilize data analysis and visualization platforms and tools by applying advanced scientific algorithms and methods, translating strategic vision into risk mitigation strategies and data visualization insights.
• Strong working knowledge of FDA and international adverse event reporting regulations (ICH, EMA GPV, GCP, etc.) and the ability to interpret and apply applicable regulations.
• Strong working knowledge of ARGUS case management and medical review processing; experience using ARGUS or other safety databases; experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications, post-marketed and pre-marketed products.
• Experience with preparation of aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs).
• Strong interpersonal skills with the ability to professionally interact with cross-functional team members.

Preferred Qualifications

• Experience in the cardiometabolic and/or rare disease space.

This position may be hired at a lower level depending on the candidate's qualifications, experience, and overall alignment with the needs of the role.

Pay

California pay range: $185,000–$210,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.