Director, Safety Science

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, Safety Science provides leadership to other safety scientists and scientific support in managing the development, implementation and oversight of Arrowhead investigational products.ResponsibilitiesLead a group of Safety Scientists across Arrowhead’s Therapeutic Areas.Supervise the Safety Scientists activities and approve documents and deliverables.Train Safety Scientists and contribute to individual scientists projects and goalsMonitor Safety activities and active membership in TST (Trial Safety Team), PST (Program Safety Team) or other Safety Governance activities.Review potential safety observations, safety signals and contribute to the 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 CommitteePrepare periodic aggregate safety reports including DSUR, FDA IND Annual Report etc.Performs routine signal detection, trend recognition in blinded and unblinded patterns for clinical trials and contribute to signal detection from the internal safety database and literature reportsIdentifies and evaluates safety signals through assessment of individual case safety reports and aggregate dataAble to give presentations of safety data to intradepartmental and interdepartmental audiencesLead and facilitate department meetings; prepare agendas and meeting minutes; assist with vendor management and oversightVendor management, budget review and CRO project coordinationKeeping updated on relevant regulations associated with the above activitiesCollaborate with cross-functional team members across the matrixOversee CRO vendors who perform local safety reporting for ArrowheadDevelop and update of Clinical Risk Management Plans for clinical studies he/she will be responsible forReview and monitor SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety database for the responsible Arrowhead programsSupports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports the Company Core Data Sheet and Risk Management PlanPrepare and update study-specific Safety Monitoring Plans and study reporting matrix as neededProvide drug safety case management support to medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data for various Arrowhead programsAssist in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studiesMonitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure effective reconciliation processLiaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety supportReview and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event (SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations)Manage and update safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory resultsMonitor safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirementsAssist in quality assurance activities, including deviation reports and generating necessaryGenerate safety queries as needed for clarification of clinical reportsConduct active case follow-up, including written and verbal follow-up with clinical operations, clinical investigators and sitesCAPA to ensure Arrowhead is meeting all safety compliance requirementsManage Arrowhead's QMS for safety/Pharmacovigilance proceduresAssist with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activitiesSupport activities associated with launching a filing for the BLA/NDA or global marketingContribute to on-going process enhancement for Arrowhead’s Safety Management Plans, Benefit Risk strategies, including developing standard procedures, work instructions and templatesRequirementsMD or DO Degree10 + years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experiencePrior experience in Safety/Pharmacovigilance OperationsStrong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medicationsExperience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)Experience in Pre marketing and post marketing Signal Detection and Safety Data Analytics is criticalStrong safety science experience to utilize data analysis and visualization platforms and tools by applying advanced scientific algorithms and methods and translating the strategic vision of safety science into risk mitigation strategies and data visualization insightsStrong working knowledge of FDA and international adverse event reporting regulations {ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulationsStrong working knowledge of ARGUS case management and processing; experience in using ARGUS or other safety databases; experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medicationsExperience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)Experience with quality assurance and compliance for drug safetyExperience in clinical trial activities, SMP development, protocol review and other Arrowhead clinical and safety documentsExpertise in Integrated Safety Summary reviews, regulatory submissions, protocol, ICF, and other documentsExperience with regulatory inspections and audits of service vendors/business partners would be helpfulGood organizational skills with the ability to perform multiple tasks efficiently and effectivelyProficiency in standard desktop software programs (Word, Excel, Outlook)Competency in presenting data, obtaining, analyzing, and reporting safety dataMotivated self-starter who can work independently, adapt to work environment, team, timelines and deliverablesStrong interpersonal skills with the ability to professionally interact with cross functional team membersThorough understanding of the drug development process and context applicable to safety surveillance activitiesTrack record in monitoring awareness dates, day zero and due dates for regulatory submissions in collaboration with the regulatory documentsPreferredExperience in data mining, extensive data analyses and oversight of safety science deliverables 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.California pay range $240,000—$260,000 USDArrowhead provides competitive salaries and an excellent benefit package. 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