Senior Director, Clinical Pharmacology

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director of Clinical Pharmacology will develop clinical pharmacology plans and deliver data packages to help advance the clinical development of a diverse pipeline of therapeutic modalities (e.g., small molecules, biologics, nucleic acid therapeutics, and gene therapies). The Senior Director will be responsible for clinical pharmacology sections of submissions to regulatory agencies and will serve as a representative in meetings with partners, collaborators, clinical investigators, and global health authorities. The Sr. Director will proactively collaborate across the company, contributing to the R&D strategy, developing clinical pharmacology strategies and executing these strategies within the Translational Sciences organization.  

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.

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

1. Develop clinical pharmacology plans and drive execution across development pipeline 
2. Serve as clinical pharmacology subject matter expert and an advisor to senior management  
3. Represent Clinical Pharmacology on project teams and cross-functional initiatives and in global health authority meetings 
4. Lead model-informed drug development across development pipeline. Conduct PK and/or PK/PD modeling to inform dosing strategies for development programs. Oversee population PK modeling and exposure response analyses at vendors for regulatory submissions 
5. Mentor junior-level scientists and may supervise a direct report(s) 
6. Ensure timely and accurate communication of study results and interpretation to internal drug development teams 
7. Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submission 
8. Author clinical pharmacology sections of NDA and/or BLA filings, clinical study reports, protocols, investigator brochures, regulatory responses, and other submissions 
9. Contribute to clinical pharmacology literature and maintain a current understanding of scientific literature relevant to development programs 

Requirements:

1. PhD or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or relevant science with 10+ years of industry experience 
2. Demonstrated understanding of translational PK and clinical pharmacology with industry experience in clinical development 
3. Experience in drug development of diverse modalities (e.g., small molecules, biologics, mRNA therapeutics) for rare diseases is preferred. Ability to rapidly master new scientific areas is essential 
4. Demonstrated proficiency with hands-on PK noncompartmental and compartmental analysis and data reporting using Phoenix WinNonlin 
5. Demonstrated experience with population PK modeling, exposure response analysis, QTc analysis, and mechanistic PK/PD modeling is desired.  
6. Capable of independently authoring and delivering Clinical Pharmacology sections of regulatory submissions  
7. Strong knowledge of drug development and FDA and ICH guidance documents 
8. Clear and influential communicator and collaborator, capable of establishing strong cross-functional partnerships with internal and external stakeholders 
9. Demonstrated understanding of bioanalytical measurement techniques for drug candidates spanning diverse modalities and therapeutic areas  

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