Vice President and Head Global Safety Science at Ultragenyx in Somerville, MA

Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team.

Position Summary:

ultrainnovative – Tackle rare and dynamic challenges

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.

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

The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.

This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Pay Range$387,800—$479,000 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to: · Generous vacation time and public holidays observed by the company · Volunteer days · Long term incentive and Employee stock purchase plans or equivalent offerings · Employee wellbeing benefits · Fitness reimbursement · Tuition sponsoring · Professional development plans * Benefits vary by region and country

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.

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