Assoc Director, Patient Safety Medical Device Safety

Role Summary

Associate Director, Patient Safety Medical Device Safety responsible for supporting activities to ensure ongoing safety oversight of Gilead’s medical devices and combination products throughout the product lifecycle, including safety reporting, post-market surveillance, risk management, and analysis of safety data sets. Will drive strategies and ensure operational excellence through collaboration with business partners. This role involves design control, clinical evaluations, vigilance/safety reporting, post-market surveillance and signal management for medical devices and combination products worldwide.

Responsibilities

• Ensure safety processes are executed and maintained throughout the product lifecycle in compliance with relevant regulations, standards, and guidelines for medical devices, combination products and diagnostics.
• Review device cases / complaints to ensure that case processing and evaluation are accurate and in compliance with regulatory requirements for safety reporting and Gilead standards. Collaborate with ICSR and Product Complaint teams to resolve issues between Global Safety and Quality databases.
• Develop training and standards for case processing and safety reporting.
• Contribute to medical device / combination product Post-Market Surveillance (PMS), including planning and report preparation. Support writing, review, and submission of device contributions in aggregate reports (PSUR/PBRER, PADER).
• Collaborate with PS Therapeutic Area leads and PS Benefit-Risk Science teams to conduct safety assessments of data sets including device complaints, device trending and signal management for combination products.
• Provide device safety contribution and collaborate with PS Therapeutic Area leads in combination product development and clinical studies.
• Collaborate with cross-functional teams in device risk management activities including identification and reduction of risks, benefit-risk analysis, and evaluation of residual risk throughout the product lifecycle.
• Review regulatory intelligence and work with PS cross-functional teams to interpret, assess impact, and update procedures with regards to device / combination product regulations.
• Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally.
• Represent PS in cross-functional working groups regarding device / combination product / diagnostic regulations and their impact to PS.
• Link with PS Alliances team regarding device requirements in PV agreements with License Partners.
• Collaborate with cross-functional teams in preparation/support of internal audits and regulatory inspections; review, respond and implement CAPAs for PS processes for medical device / combination product.
• Develop solutions to a wide range of complex problems, ensuring consistency with organizational objectives.
• Foster a culture of collaboration and communication to drive business objectives.
• Drive a culture of continuous improvement to enhance PS processes and safety oversight.
• Stay abreast of industry trends and best practices in the medical device / combination product space.

Qualifications

• Required: BA/BS with 10+ years’ relevant experience
• Required: MA/MS/MBA with 8+ years’ relevant experience
• Required: PhD/PharmD with 5+ years’ relevant experience
• Preferred: Health care professional degree, preferably Nursing or Biomedical Engineering
• Preferred: Extensive medical device / combination product safety experience; background in pharmacovigilance and device safety activities
• Preferred: Thorough understanding of global device / combination product regulations and standards for design control, risk management, vigilance/safety reporting, and post-market surveillance; ability to translate requirements into safety processes
• Preferred: Experience navigating a matrix organization
• Preferred: Track record of leading complex, large-scale, time-sensitive projects
• Preferred: Strong relationship-building, collaboration, negotiation, and communication skills
• Preferred: Excellent written and verbal communication; ability to produce clear documents and presentations
• Preferred: Ability to prioritize and manage multiple projects
• Preferred: Willingness to travel when needed

Additional Requirements

• When needed, ability to travel.