Senior Director, Clinical Pharmacology
Ultragenyx
full-time
Posted on:
Location Type: Hybrid
Location: Brisbane • California • United States
Visit company websiteExplore more
Salary
💰 $284,600 - $351,500 per year
Job Level
About the role
- 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
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical pharmacologypharmacokineticsPK/PD modelingpopulation PK modelingexposure response analysisnoncompartmental analysiscompartmental analysisdata reportingauthoring regulatory submissionsbioanalytical measurement techniques
Soft Skills
communicationcollaborationmentoringleadershipinfluential communicationcross-functional partnershiptimely communicationinterpretation of study resultsadaptabilityscientific literature understanding
Certifications
PhD in pharmacokineticsPhD in pharmacologyPhD in pharmaceutical sciences