Job Title

Senior Scientist, Clinical Pharmacology & DMPKBrisbane, CAWhy Join Us?Be a hero for our rare disease patientsAt 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 wont 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:As a Senior Scientist in Clinical Pharmacology & DMPK, you will be a self-starter with excellent scientific leadership capabilities. You will be part of an innovative Clinical Pharmacology & DMPK team that efficiently drives the translation of drug concepts from preclinical pharmacology studies through clinical development and lifecycle management. You will be responsible for the delivery of ADME and clinical pharmacology plans and data to help advance a pipeline of diverse modalities for Ultragenyx. You will contribute to the preparation of documents for regulatory agency meetings and will serve as a representative in meetings with project teams and collaborators.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.Responsibilities:Serve as Clinical Pharmacology or DMPK representative on project teams.Develop DMPK and clinical pharmacology plans and execute strategies for programs from IND stage through clinical development.Evaluate and perform hands-on analysis of nonclinical or clinical PK/PD data.Ensure timely and accurate communication of study results and interpretation to internal drug development teams.Author clinical pharmacology and ADME sections of study reports, protocols, investigator brochures, and other regulatory submissions.Conduct PK/PD analyses and modeling to inform FIH dosing strategies.Maintain a current understanding of clinical pharmacology and DMPK literature and methodology, as well as literature related to specific drug development projects.Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submissions.Requirements:PhD or equivalent degree in pharmacokinetics, pharmacology, or pharmaceutical science.Demonstrated understanding of ADME, pharmacokinetics, and clinical pharmacology with 5-8 years of related industry experience, including clinical development.Demonstrated proficiency with hands-on noncompartmental PK analysis and data reporting using Phoenix WinNonlin.Excellent interpersonal skills and demonstrated ability to represent Clinical Pharmacology and DMPK in a collaborative team environment.Excellent written and verbal communication skills and ability to explain complex technical information.Understanding of bioanalytical methods related to PK/PD/immunogenicity.Experience with diverse drug modalities (e.g., small molecules, biologics, mRNA therapeutics) is preferred.Knowledge of relevant FDA and ICH guidance documents.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.Pay Range: $147,500 - $182,200 USDFull Time employees across the globe enjoy a range of benefits, including, but not limited to:Generous vacation time and public holidays observed by the companyLong term incentive and Employee stock purchase plans or equivalent offeringsFitness reimbursement* 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. #J-18808-Ljbffr