Hybrid Associate Director, Patient Safety – Medical Device Safety

at Gilead Sciences

• Job title: Associate Director, Patient Safety – Medical Device Safety
• Job type: Full Time
• Experience level: Lead
• Salary: $177,905 - $230,230 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Foster City, United States

About the role

• Associate Director for Patient Safety Medical Device Safety at Gilead, ensuring safety oversight of medical devices and combination products. Driving operational excellence and collaboration for patient safety.

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
• Closely collaborate with ICSR and Product Complaint teams to resolve any issues, inconsistencies or inaccuracies identified between the Global Safety database and Quality database
• 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 applicable device contribution 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, as well as 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 team in device risk management activities including identification and reduction of risks associated with Gilead’s medical devices / combination products, conducting benefit-risk analysis, and evaluating overall residual risk acceptability throughout the lifecycle of the product
• Review regulatory intelligence and work with PS cross functional team to interpret, assess impact, and update processes and procedures with regards to device / combination product regulations requirements and updates as required
• Collaborate with PS Affiliate leads regarding local regulatory requirements and coordinate globally
• Represent PS in cross functional working groups and teams with regards to device / combination product / diagnostic regulations and its impact to PS
• Link with PS Alliances team regarding device requirements needed in PV agreements with License Partners
• Collaborate with cross-functional teams in the preparation and/or support of internal audits and regulatory agency inspections; reviews, responds and implement corrective and preventive actions with respect to findings on PS processes for medical device / combination product
• Develop solutions to a wide range of complex problems, ensuring solutions are consistent with organization 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, emerging topics, and best practices in the medical device / combination product space

Requirements

• BA/BS with 10+ years’ relevant experience OR MA/MS/MBA with 8+ years’ relevant experience OR PhD/PharmD with 5+ years’ relevant experience
• Health care professional degree preferably Nursing or Biomedical Engineering degree
• Extensive medical device / combination product safety or related experience
• Previous experience in pharmacovigilance and device safety activities
• Thorough understanding and application of medical device / combination product regulations and industry standards globally for design control, device risk management, vigilance / safety reporting, and post-market surveillance throughout the product lifecycle
• Experience translating these requirements into medical device safety processes, in particular risk management, device vigilance / safety reporting and post-market surveillance preferred
• Significant experience in navigating a matrix organization
• Track record of successfully leading complex, large scale, time-sensitive projects
• Strong relationship building skills, and ability to collaborate, influence and negotiate to work effectively with cross-functional teams to meet project timelines and patient needs
• Excellent verbal, written, and interpersonal communication skills
• Ability to write clear and concise documents/presentations
• Ability to prioritize and manage across multiple competing projects
• When needed, ability to travel.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives
• paid time off
• benefits package