Senior Scientist, Clinical Pharmacology & DMPK at Ultragenyx in Brisbane, CA

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:

ultrafocused – Work together to fearlessly uncover new possibilities

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 #LI-CS1 #LI-Hybrid

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$147,500—$182,200 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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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.