Senior Director, Clinical Pharmacology
Ultragenyx Pharmaceutical Inc.
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:
- 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
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
#LI-CT1 #LI-Hybrid #LI-Remote
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.