Senior Scientist, DMPK

Position Summary:

As a Senior Scientist in DMPK at Ultragenyx, you will be part of the preclinical translational science team that efficiently advances rare disease drug pipeline from preclinical studies through clinical development. You will have the opportunity to work on diverse drug modalities (AAV, oligonucleotide, small molecules, biologics) and will be responsible for characterization of their ADME, PK, and PK/PD properties to support preclinical development programs and clinical translation. You will be empowered to serve as a DMPK representative in project teams to provide data interpretation and engage in strategic decision-making discussions. In addition, you will actively contribute to the preparation of nonclinical documents for regulatory filings and interactions.

ultradedicated - 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:

• Evaluate the ADME properties of investigational therapeutics in pre-clinical species to guide candidate selection for clinical development
• Design, analyze, and interpret PK and PK/PD studies and data in pre-clinical species through internal and external collaborations
• Integrate pre-clinical DMPK/pharmacology data to characterize PK/PD relationships of drug candidates
• Utilize integrated preclinical data to provide first-in-human dose recommendations for different drug modalities and disease indications
• Serve as the DMPK representative on cross-functional project teams and actively contribute to strategic discussions on the development of preclinical drug candidates
• Author and review ADME sections of study reports, nonclinical study protocols, and regulatory documents
• Maintain a current understanding of DMPK literature and methodology, as well as scientific literature related to specific drug development projects

Requirements:

• PhD or equivalent degree in pharmacology, pharmaceutical science, molecular biology, or a related field and at least 5-8 years of relevant industry experience in DMPK
• Strong knowledge of in vitro and in vivo DMPK assays and bioanalytical methods to evaluate ADME properties of drug candidates
• Proficiency in hands-on PK NCA analysis and data reporting using Phoenix WinNonlin. Experience with PK/PD modeling is preferred.
• Excellent communication (oral and written), organizational, and interpersonal skills
• Familiar with regulatory requirements and experience supporting regulatory filings with contributions to ADME sections of regulatory documents
• Demonstrated ability to work independently and lead cross-functional collaborations
• Experience with diverse drug modalities (e.g., small molecules, biologics, oligonucleotides) is preferred.
• Experience in performing cell-based molecular assays is preferred.

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