Associate Medical Director/Medical Director, Clinical Safety and Pharmacovigilance

The Position

 The Associate Medical Director/Medical Director, Clinical Safety will provide day-to-day Medical Safety oversight, and scientific support in managing the development, implementation and oversight of Arrowhead investigational products with engaging in, but not limited to: Adverse Event Review, Laboratory Abnormalities, Clinical Safety Signal, support safety governance and surveillance procedures in compliance with Arrowhead’s internal standard operating procedures, FDA and global safety reporting requirements. The Associate Medical Director/Medical Director will conduct trend recognition, signal detection, safety lab review, and assist in overseeing relationships with CRO Medical Monitors, and other business partners to ensure the highest quality of clinical safety data is collected, reviewed and analyzed which fulfill all safety reporting requirements are met in the required timelines.

The Associate Medical Director/Medical Director will collaborate with medical monitors, clinical operations, QA and regulatory colleagues in the set-up of and support of new clinical development programs to ensure the preparation of safety documents and data. These collaborative efforts will continue throughout the duration of the clinical program supporting Data Monitor Committee activities, Risk Assessments, Investigator Brochure, protocol and Informed Consent reviews.

The Associate Medical Director/Medical Director will assist in the development, implementation, and monitoring of safety policies/standard operating procedures.

Responsibilities

• Monitor Adverse Events, Safety Labs, Safety monitoring activities in collaboration with internal and external Medical Monitors in accordance with Arrowhead’s Safety and Medical Surveillance Plans
• Key participation and membership in Arrowhead’s Safety Governance: 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 Committee
• Participate in department meetings; prepare agendas and meeting minutes; assist with vendor management and oversight
• Collaborate with CRO Medical Monitor and provide Medical and Safety Oversight of clinical trial participants
• Support periodic aggregate safety reports including DSUR, FDA IND Annual Report
• 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 reports
• Identifies and evaluates safety signals through assessment of individual case safety reports and aggregate data
• Able to give presentations of safety data to intradepartmental and interdepartmental audiences
• Collaborate with cross-functional team members across the matrix such as Clinical Operations, Clinical Development, Regulatory Affairs, Medical Affairs and others
• Oversee CRO Medical Safety Monitoring local safety monitoring for Arrowhead
• Develop and update of Clinical Risk Management Plans for clinical studies he/she will be responsible for
• Review and monitor AEs/SAE case processing including, performing the secondary quality review for all case reports in the safety database for the responsible Arrowhead programs
• Prepare and update study-specific Safety Monitoring Plans
• Provide 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 programs
• Assist in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies
• Review 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 results
• Monitor safety surveillance for Arrowhead’s clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
• Assist in quality assurance activities, including deviation reports and generating necessary
• Generate safety queries as needed for clarification of clinical reports
• Conduct active case follow-up, including written and verbal follow-up with clinical operations, clinical investigators and sites
• CAPA to ensure Arrowhead is meeting all safety compliance requirements
• Manage Arrowhead’s QMS for safety/Pharmacovigilance procedures
• Assist with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities
• Support activities associated with launching a filing for the BLA/NDA or global marketing
• Contribute to on-going process enhancement for Arrowhead’s Safety Management Plans, Benefit Risk strategies, including developing standard procedures, work instructions and templates

Requirements:

• An MD (or equivalent) with 5 years in the pharmaceutical industry or CRO as a Medical Monitor, Medical Director, Clinical Scientist or Safety Scientist, and/or a similar combination of education and experience in Academia or Clinical Practice
• Minimum of 3 years’ experience working on clinical trials
• Experience lab review, AE review, Signal Detection and Safety Data Analytics
• Experience in Medical Monitoring as a clinical or safety scientist
• Strong Clinical Science and Medical Monitoring 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 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.
• Experience 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 safety
• Experience in clinical trial activities, SMP development, protocol review and other Arrowhead clinical and safety documents.
• Expertise in reviewing laboratory results, AE review, AE management, also Integrated Safety Summary reviews, regulatory submissions, protocol, ICF, and other documents.
• Competency in presenting data, obtaining, analyzing, and reporting safety data
• Motivated self-starter who can work independently, adapt to fast-paced work environment, team, timelines and deliverables.
• Strong interpersonal skills with the ability to professionally interact with cross functional team members.
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Track record in monitoring awareness dates, day zero and due dates for regulatory submissions in collaboration with the regulatory documents.
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively
• Proficiency in standard desktop software programs (Word, Excel, Outlook)

Preferred:

• Up to date knowledge of the new developments in RNA interference therapeutics landscape in industry and academia