Executive Director

Description:

The ED Safety Science in Global Drug Safety & Pharmacovigilance (DSPV) will serve as the medical safety expert accountable for the global benefit risk strategy and overall safety profile for a portfolio of Ultragenyx marketed and clinical development products throughout the product(s) lifecycle. This includes leading all major pre- and post- marketing safety deliverables including signal, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. The ED Safety Science will work together with DSPV staff and other stakeholders in managing the safety assessment of products, including review of individual and aggregate safety data and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The experienced individual must have executive presence, superb written and verbal communication skills, and the ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

Responsibilities:
Direct and oversee medical/scientific assessments of all safety data including the preparation and review of individual case safety reports (ICSRs), data monitoring and safety endpoint adjudication and safety-related section(s) for PV, clinical, regulatory, and scientific documents including signaling reports, aggregate safety reports (PSURs/DSURs/PADER, 6-monthly SUSAR Line Listings), core safety labeling, protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring accuracy of safety and benefit-risk profiles for all programs
Manage all pre- and post-marketing safety surveillance activities for assigned Ultragenyx products (investigational and marketed) throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and Ultragenyx policies and procedures. 
Establish effective collaboration with DSPV, Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Affairs and other functional areas to align on harmonized approach in identifying, evaluating, validating, and communicating safety issues
Lead and/or provide input to global safety strategy ensuring proactive and continuous review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for assigned programs in collaboration with key stakeholders
Provide DSPV leadership and input for Clinical Development programs including Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs; liaise with internal and external stakeholders including 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
Provide PV Leadership in the review, assessment and presentation of new safety findings at Development Technical Review Forum (DTRF) or other Safety Governance forums to communicate product safety/risk profile to key stakeholders. Lead the safety aspect of interactions with Regulatory authorities worldwide (FDA, EMA etc.) at type C, B, pre-BLA/MAA/NDS meetings, Scientific Advice, Advisory Committee meetings, or other scientific advice forums
Provide medical review of individual case safety reports (clinical and spontaneous) and all safety analyses to ensure accurate coding (MedDRA and WHODrug), seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and business partners. 

Requirements:

MD Or Equivalent Required
MD or MD/PhD. DO; with subspeciality training in neuroscience, immunology, or metabolic disease, or experience in rare disease drug development preferred. Clinical experience highly recommended
A minimum of 12 years in a senior/advanced PV role within the pharmaceutical/biotechnology industry; other relevant experience may be considered
Excellent communication and influencing skills within the function (up and down) as well as cross- functional; success influencing executives and senior level scientific management as well as external representation of company
Requires high level of initiative and independence
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
Able to interface well with all levels of personnel, including peers and other Development and Commercial department heads such as: Biostatistics, Clinical, Commercial, Medical Affairs, Program Management, Regulatory Affairs, Quality
Capacity to produce high quality results across multiple programs and non-program initiatives and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment
Demonstrated knowledge of pharmaceutical research and development, global safety and PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, ICH guidelines and regulations pertaining to clinical development and post- marketing safety and their interpretation
Experience working in innovative and groundbreaking therapies with demonstrated track record of accomplishments with high visibility programs
Willingness to travel. There may be circumstances where business needs require remote team members to travel / work in the office including national / international travel