Ultragenyx Pharmaceutical Inc.
Director/Senior Director, Safety Science
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. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing.
US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
Roles based outside the US: If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.
Position Summary:
ultracurious – Apply your biggest ideas in courageous ways
The Director/Senior Director Safety Science, Global Drug Safety & Pharmacovigilance (DSPV) serves as the safety expert accountable for the global safety strategy and overall safety profile for assigned Ultragenyx programs/products (investigational and marketed) throughout their product 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. This individual will work together with Global 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.
Work Model:
Remote: officially documented as working full time from home, with travel to Ultragenyx's offices or other location on occasion as needed.
Responsibilities:
- 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 procedures
- Lead and provide input to global safety strategy ensuring review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for assigned programs in collaboration with essential stakeholders
- Provide DSPV leadership and input for Clinical Development Programs including Clinical, Investigator Sponsored, Compassionate Use, Named Patient Use, and Disease Monitoring Programs; work with Clinical Science, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy, quality, compliance and operational excellence
- Participate on Program Core Team (PCT), Development Sub-Team (DST), Study Management Team (SMT) and other decision-making forums for assigned programs
- Lead the safety aspect of interactions with Regulatory authorities worldwide (FDA, EMA ) at type C, B, pre-BLA/MAA/NDS meetings, Advisory Committee meetings, or other scientific advice forums
- Provide DSPV leadership to support Ultragenyx Commercial organization global launch activities for assigned programs
- Establish collaboration with DSPV, Clinical Science, Clinical Operations, Regulatory Affairs, Biometrics, and Medical Affairs and other departments to agree on harmonized approach in communicating safety issues
- 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 partners
- Lead and contribute to the preparation and review of medical/scientific assessments of safety data including safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical analysis plans, clinical study reports/synopses, integrated summaries of safety (ISS), 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, ensuring safety profile reflected for assigned products
- Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling
- Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products
- Lead signal detection activities to ensure signal identification, evaluation, validation, for assigned products including personal and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with important partners
- Lead and contribute to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports
- Lead risk-benefit evaluations, the preparation and review of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements
- Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data
- Demonstrate knowledge and ensure compliance with current and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH), Ultragenyx SOPs and quality standards
- Involved in inspection readiness activities, internal audits and external inspections
- Participate in the PV vendor selection activities and contribute to the generation of Pharmacovigilance Agreements (PVAs) or Safety Data Exchange Agreements (SDEAs)
- Contribute to vendor governance activities and measurements to ensure DSPV excellence
Requirements:
- Bachelor’s level degree with advanced degree preferably in scientific field; Healthcare professional degree preferred (MD, MPH, PharmD, RPh, RN/BSN).
- 10-12 years industry experience
- Knowledge of pharmaceutical research and development, global safety and PV regulatory environment with working knowledge of international regulations, programs, standards of Good Pharmacovigilance Practices (GVP) including, Americas, European, Latin-America and Asia-Pacific territories including FDA, EMA, ICH guidelines on clinical development and post-marketing safety and their interpretation
- Experience in all phases of biologic, small molecule, mRNA and gene therapy drug development
- BLA/MAA experience preferred with success working with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.
- Experience in the principles and techniques of data analysis, proficient in data analysis software and data presentation; interpretation and clinical relevance
- Experience developing risk management strategies and plans
- Working knowledge of industry standard safety databases (ARGUS and ARISg), Regulatory databases, and other electronic data capture systems
- MedDRA trained and working knowledge of MedDRA and WHODrug dictionaries
- Real-world supporting PV audits and health authority inspections
- Domestic / international travel may be required
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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 & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
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Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.