Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

As a Principal Scientist / Director in Clinical Pharmacology, 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 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 representative on project teams.
• Develop clinical pharmacology plans and execute strategies for programs from IND stage through clinical development
• Evaluate and perform hands-on analysis of clinical PK/PD data
• Ensure timely and accurate communication of study results and interpretation to internal drug development teams
• Author clinical pharmacology sections of study reports, protocols, investigator brochures, and other regulatory submissions
• Collaborate with DMPK on 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 a minimum of 10+ 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 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