Ultragenyx seeks a highly experienced dynamic leader and manager to head up the Global Safety Science function within Ultragenyx’s Global Drug Safety & Pharmacovigilance (DSPV) department. The individual will be a self-starter with excellent management and leadership capabilities who is seeking to lead and be part of an innovative team that will drive the overall safety strategy & surveillance practices for Ultragenyx’s portfolio of marketed and development products. The experienced individual must have executive presence, advanced benefit-risk/safety data analyses experience, superb written and verbal communication skills, as well as hands-on PV experience with a proven track record of major accomplishments.

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Or

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Guides, coaches, manages and builds a team of Safety Science professionals and leaders to ensure their professional development and advancement
• Provide Senior PV Leadership input to global safety strategy for all programs throughout lifecycle ensuring proactive and continuous review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for all Ultragenyx programs in collaboration with key stakeholders and in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and Ultragenyx policies and procedures
• Provide Senior PV Leadership in Development Technical Forums, Product Safety, Quality and other Governance Committees and making recommendations regarding product safety/risk profile, risk management, labeling and communication planning
• Provide Senior PV Leadership in the development and maintenance of Reference Safety Information (RSI) including Company Core Data Sheet (CCDS), Investigator Brochure (IB), and/or other product labeling and participate in Labeling forums ensuring accurate safety profile for all Ultragenyx products
• Provide Senior PV Leadership in risk analyses contributing to the benefit-risk profile, designing, implementing and measuring effectiveness of risk minimization measures & risk management strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance, Enhanced Pharmacovigilance) in collaboration with other stakeholders to ensure the safe and appropriate use of Ultragenyx approved products in compliance with global regulatory requirements
• Direct and oversee Safety Science strategy for all Ultragenyx programs including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs; liaise with Contract Research Organizations (CROs), Data Monitoring and Steering Committees and other entities to contribute to overall study execution while ensuring safety monitoring, quality, compliance and operational excellence
• Direct and oversee monitoring and medical/scientific assessments of safety data including and not limited to individual case safety reports (ICSRs), signaling, aggregate safety reports, protocols, clinical study reports, integrated safety summaries/dossiers, and abstracts/manuscripts ensuring accuracy of safety and benefit-risk profiles for all programs
• Provide Senior PV Leadership and/or lead the safety aspect of interactions with Regulatory authorities worldwide for IND/CTA, NDA/BLA/MAA, Advisory Committee meetings, or other scientific advice forums
• Develop, implement and maintain PV System for safety surveillance processes and practices that are compliant, robust, and right sized to support Ultragenyx business model
• Execute all safety surveillance activities ensuring quality, compliance and key performance metrics met for ICSR management, signal and risk management activities, aggregate safety reporting, core safety labeling, responses to regulatory requests for safety information and others
• Lead inspection readiness activities, internal audits, and external inspections for Safety Science

Requirements:

• MD or equivalent degree required.
• Minimum of 15 years in a senior/advanced PV Science role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacity; other relevant experience may be considered
• Rare disease experience in all phases of biologic, small molecule, mRNA and gene therapy drug development preferred including IND/CTA, NDA/BLA/MAA experience with success interacting with Regulatory authorities, Advisory Committees, or other scientific advice forums
• Excellent interpersonal, communication, and influencing skills (up and down); success influencing executives and senior level scientific management as well as external representation of company
• Requires high level of initiative, independence, and ability to navigate fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must
• Strong people management skills, willingness to develop team and help others succeed
• Demonstrated ability to work in a matrix environment with cross-functional teams
• Up to 20% annual travel (domestic and international) is required for this positionte