Associate Director, Global Patient Safety, Risk Management - Cellular Therapy

Job Description

Associate Director, Global Patient Safety (GLPS), Risk Management (RM) - Cellular Therapy

Specific Responsibilities

• Authors of European Union (EU) Risk Management Plans (RMPs) and Development RMPs for cellular therapy products
• Participates in development of strategies for routine and additional risk minimization and PV measures, as applicable, in collaboration with Pharmacovigilance & Epidemiology Physicians
• Contributes to development and execution of Risk Evaluation and Mitigation Strategy (REMS), including the associated Elements to Assure Safe Use (ETASU), as applicable
• Participates in or may lead cross-functional teams (e.g., Working Groups, Committees, etc.), involving interactions with Kite/Gilead staff within and external to GLPS, to ensure timely advancement of deliverables and submission to health authorities as required
• Authors responses to safety enquiries received from global regulatory agencies
• Supports regulatory filing activities including analyses of aggregate safety data, review of filing documents (e.g., CSRs, ISSs, etc.)
• Reviews draft periodic reports (e.g., PSUR/PBRER, PADER, DSUR, etc.);  may author relevant sections as needed
• May contribute to scientific and strategic input in development and execution of Post Authorization Safety Studies (PASSs), including Long-term follow up/Registry studies

Essential Duties and Job Functions

• Offers significant contributions to discussions at safety governance meetings (e.g., SMT, etc), as applicable, for cellular therapy products
• Presents results and findings from risk management activities (e.g. RMP, REMS, etc.) and applicable processes in formal settings as needed
• Leads multiple projects simultaneously with minimal supervision
• Leads the analysis and resolution of complex problems collaboratively with cross-functional staff
• May write drug safety SOPs and contribute to drug safety audits or inspections
• Work is performed under minimal supervision following established procedures
• Establishes recognition within GLPS as an expert in pharmacovigilance
• Anticipates complex problems which may arise and resolves them in a collaborative manner
• Demonstrates independent thought and initiative in the preparation and completion of projects

Basic Qualifications

• BS/BA in healthcare or scientific field with 10 years of experience in pharmaceutical or biotech industry
• Master’s degree in healthcare or scientific field with 8 years of experience in pharmaceutical or biotech industry
• Phd, MD or PharmD or equivalent degree with 6 years of experience in pharmaceutical or biotech industry

Preferred Qualifications

• Typically requires an advanced degree (e.g., MS,  PharmD, or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific discipline with demonstrated experience with the responsibilities, deliverables, and skills required for this level
• 8+ years in the pharmaceutical or biotech industry
• 6+ years direct experience in PV/Risk Management
• Direct experience in authoring RMPs required
• Excellent knowledge of pharmacovigilance regulations, risk management plans, risk minimization/PV measures, signal detection, clinical trials and clinical development
• Demonstrates proficiency in verbal and written communication, including Microsoft Office, Excel, Word, and PowerPoint
• Demonstrates excellent attention to detail, project management skills, teamwork and initiative; maintains meticulous attention to project deadlines
• Demonstrates ability to influence others at the same or more junior levels within the organization
• Demonstrates excellent interpersonal and communications skills and ensures that all customers are fully informed and knowledgeable of project activities and their status
• Demonstrates ability to assess complex data sets and understand the safety/medical implications
• Demonstrates understanding of observational studies used in pharmacoepidemiology