Associate Director/Director, Clinical Pharmacology
Ultragenyx is a clinical stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases with an initial focus on serious debilitating metabolic genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of both large and small molecule candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Come join our team during this exciting time of growth and opportunities!
We are headquartered in Novato, CA, 25 miles north of San Francisco, and we also have an office in Brisbane, CA, 10 miles south of San Francisco. This position can be located in Novato or Brisbane.
The Director, Clinical Pharmacology acts as the primary clinical pharmacology lead providing clinical pharmacology expertise to a multidisciplinary study team. The Associate Director, Clinical Pharmacology is responsible for clinical pharmacology programs for assigned projects and will be the key expert on all clinical pharmacology & pharmacometrics matters relating to assigned projects. The Associate Director, Clinical Pharmacology will work in close collaboration with different functions including non-clinical, Research, Regulatory, BioMetrics and Clinical. This position reports into the Pharmacology and Toxicology organization.
Responsibilities, including but not limited to:
- Evaluate and perform hands-on analysis of clinical PK/PD data; authorize PK clinical study reports
- Provide PK/PD modeling to support dosing strategies for clinical programs
- Contribute to clinical pharmacology strategy and planning for clinical programs
- Provide mentorship and guidance to junior scientists with potential supervisory role
- Ensure timely and accurate communication of study results and interpretation to appropriate internal drug development teams
- Write and edit dose rationale sections of clinical protocols and investigator brochures
- Maintain a current understanding of small and large molecule PK literature and methodology, as well as the scientific literature related to the specific drug discovery projects
- Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements
- PhD or equivalent in pharmacokinetics, pharmacology or pharmaceutical science is required; industry experience in conducting clinical stage drug development is strongly preferred
- Must be proficient with hands-on PK NCA analysis and data reporting using Phoenix WinNonlin
- Population PK/PD analysis using NONMEM or NLME is desired; PBPK modeling experience is a plus
- Demonstrated understanding and experience in clinical pharmacology is required
- Experience in writing ADME and/or Clinical Pharmacology sections of regulatory submission documents
- Experience evaluating the pharmacokinetic properties of therapeutic antibodies is preferred
- Experience in working as a PI with external CROs with timely delivery of clear and accurate well written study findings
- Strong knowledge of clinical drug development and FDA and ICH guidance documents is essential
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: email@example.com.