Sr. Director, Bioanalytical and Biomarker Development

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 :

The Bioanalytical Development & Biomarker Strategy subject matter expert plays a critical, individual contributor role in shaping and executing bioanalytical and biomarker strategies across therapeutic programs. This role combines deep scientific expertise, strategic insight, and cross-functional leadership to ensure high-quality data generation and regulatory compliance in support of drug development.

ultra dedicated - Your biggest challenges yield rare possibilities

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 :

• Specialized Scientific Expertise : Apply deep understanding of disease biology and therapeutic mechanisms of action to guide bioanalytical strategy. Lead assay development, qualification, validation, and execution for measuring drugs (across modalities), metabolites, biomarkers, and other analytes in biological matrices
• Strategic input Into Analytical Methods : Select appropriate bioanalytical approaches tailored to therapeutic modalities (e.g., small molecules, biologics, gene therapies). Collaborate with laboratory teams to develop and validate PK, PD, immunogenicity, and biomarker assays. Ensure analytical methods meet regulatory standards and are fit-for-purpose and validation-ready. Serve as a subject matter expert in resolving complex analytical challenges and integrating cutting-edge technologies
• Significant knowledge on the Regulatory processes : Ensure bioanalytical studies comply with GLP / GCP / GMP and other relevant regulatory standards. Review non-clinical and clinical protocols for sample strategy and biological relevance. Author and review bioanalytical reports, protocols, and regulatory submission content. Partner with compliance teams to identify and qualify CROs for regulated studies
• Cross-functional Collaboration : Work closely with translational science, clinical development, data management, biostatistics, clinical operations, and regulatory affairs to integrate bioanalytical strategies into program plans. Facilitate method development and transfer to internal or external labs for regulatory support. Communicate complex scientific concepts effectively to non-expert stakeholders
• Data management and Interpretation : Deliver high-quality bioanalytical data within tight timelines while maintaining scientific integrity. Oversee integration of complex datasets from diverse analytical platforms. Translate bioanalytical and biomarker data into actionable insights for drug development. Build strong partnerships with pharmacokineticists, pharmacometricians, and clinical pharmacology scientists
• External Landscape : Monitor industry trends, emerging technologies, and evolving regulatory guidance in bioanalysis and biomarkers. Engage with external consortia, working groups, and regulatory bodies to influence industry standards and best practices

Requirements :

Skills and Expertise :

Lab :

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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$258,300—$319,100 USD Full Time employees across the globe enjoy a range of benefits, including, but not limited to :

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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