Senior Director, Clinical Pharmacology

Ultragenyx Pharmaceutical•Brisbane, CA

10h•Hybrid

About The Position

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: 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.

Requirements

PhD or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or relevant science with 10+ 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, mRNA therapeutics) for rare diseases is preferred. Ability to rapidly master new scientific areas is essential
Demonstrated proficiency with hands-on PK noncompartmental and compartmental analysis and data reporting using Phoenix WinNonlin
Demonstrated experience with population PK modeling, exposure response analysis, QTc analysis, and mechanistic PK/PD modeling is desired.
Capable of independently authoring and delivering Clinical Pharmacology sections of regulatory submissions
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
Demonstrated understanding of bioanalytical measurement techniques for drug candidates spanning diverse modalities and therapeutic areas

Responsibilities

Develop clinical pharmacology plans 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. 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
Mentor junior-level scientists and may supervise a direct report(s)
Ensure timely and accurate communication of study results and interpretation to internal drug development teams
Ensure appropriate quality of documentation for internal studies compatible with requirements for global regulatory submission
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