Senior Director, Clinical Pharmacology

1 month ago

Brisbane, United States Ultragenyx Pharmaceuticals Inc. Full time

Position Summary:

ultraimpact - Make a difference for those who need it most

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 Sr. 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 the clinical pharmacology strategy, and executing these strategies within the Translational Sciences organization.

Work Model:

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

Or

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:

* Develop clinical pharmacology strategies and drive execution across development pipeline
* Serve as clinical pharmacology subject matter expert and an advisor to senior management
* Represent Clinical Pharmacology on project teams and cross-functional initiatives and in global health authority meetings
* Lead model-informed drug development across development pipeline
* Perform business development due diligence assessments
* Mentor junior-level scientists and may supervise a direct report(s)
* Evaluate and perform hands-on analysis of clinical PK/PD data
* Conduct PK/PD modeling to inform dosing strategies for development programs
* Ensure timely and accurate communication of study results and interpretation to internal drug development teams
* Author clinical pharmacology sections of NDA and/or BLA filings, clinical study reports, protocols, investigator brochures, regulatory responses, and other submissions
* Contribute to clinical pharmacology literature and maintain a current understanding of scientific literature relevant to development programs
* Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submission

Requirements:

* PhD or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or relevant science with 12+ years of industry experience.
* Demonstrated understanding of translational PK and clinical pharmacology with industry experience in clinical development.
* Experience in drug development of diverse modalities (e.g., small molecules, biologics, nucleic acid therapeutics, and gene therapies) for rare diseases is preferred. Ability to rapidly master new scientific areas is essential.
* Demonstrated proficiency with hands-on PK noncompartmental analysis and data reporting using Phoenix WinNonlin
* Demonstrated experience with exposure-response analysis, concentration QTc analysis, mechanistic PK/PD modeling, and population PK modeling is desired.
* Capable of independently authoring and delivering ADME and Clinical Pharmacology sections of regulatory submissions
* Understanding of bioanalytical techniques and methods for measuring drug levels and anti-drug antibody responses
* Experience working as a PI with external CROs with timely delivery of clear and accurate study reports.
* Strong knowledge of drug development and FDA and ICH guidance documents
* Clear and influential communicator and collaborator, capable of establishing strong cross-functional partnerships with internal and external stakeholders.
* Understanding of bioanalytical measurement techniques and method development for drug candidates spanning diverse modalities and therapeutic areas. #LI-CK1 #LI-Hybrid #LI-Remote

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