The Senior Director of Clinical Pharmacology will develop clinical pharmacology plans and deliver data packages to advance the clinical development of a diverse pipeline of therapeutic modalities, including small molecules, biologics, nucleic acid therapeutics, and gene therapies. This role will serve as a subject matter expert, represent the company in meetings with global health authorities, and contribute to regulatory submissions and cross-functional R&D strategy within the Translational Sciences organization at Ultragenyx Pharmaceutical.
What You'll Do
- 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
What We're Looking For
- PhD or equivalent in pharmacokinetics, pharmacology, pharmaceutical sciences, or relevant science
- 10+ years of industry experience
- Demonstrated understanding of translational PK and clinical pharmacology with industry experience in clinical development
- 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
- 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
Nice to Have
- Experience in drug development of diverse modalities (e.g., small molecules, biologics, mRNA therapeutics) for rare diseases is preferred
- Demonstrated experience with population PK modeling, exposure response analysis, QTc analysis, and mechanistic PK/PD modeling is desired
Technical Stack
- Phoenix WinNonlin
Benefits & Compensation
- Generous vacation time and public holidays observed by the company
- Volunteer days
- Long term incentive and Employee stock purchase plans or equivalent offerings
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsoring
- Professional development plans
- Compensation: $284,600 - $351,500 USD base salary, equity incentives, and annual bonus
Work Mode
- Hybrid work model
- 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
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.
