Why Join Us?
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 located in Novato, CA, 25 miles north of San Francisco with additional office space in Brisbane, CA.
Ultragenyx is looking for an Associate Director/Senior Scientist, Toxicology with the passion and creativity to develop great medicines for rare and ultra-rare diseases. The individual will be a self-starter with strong leadership capabilities and who is seeking to be part of an innovative team that will drive the efficient translation of drug concepts into proof of concept studies in models and to the clinic.
This position will report to the Senior Director of Toxicology. The Associate Director/Senior Scientist, Toxicology will be a part of an innovative department where scientists will utilize cutting edge strategies and technologies to explore and help optimize the drug development process. The incumbent will be responsible for the delivery of preclinical toxicology plans and data to help progress the small and large molecule research pipeline for Ultragenyx. The incumbent will also be responsible for the preparation of documents for regulatory agency meetings and will serve as a representative in meetings with partners, collaborators, preclinical/clinical investigators, and regulatory agencies. The incumbent is expected to actively and energetically collaborate across the company, contribute to the R&D strategy, and execute the strategy within the Development organization. The Associate Director/Senior Scientist, Toxicology may also have management responsibilities for other scientists and/or technical staff as the group grows.
This is a unique opportunity to join an early stage biotech company focused on developing life transforming therapeutics for patients with rare diseases. This position will be instrumental in bringing late development stage projects to commercial launch and be a critical part of creating an innovation engine for the generation of the company’s next generation of products.
Responsibilities, including but not limited to:
• Works closely with Pharm/Tox, Research, Development, Regulatory and Clinical Development to develop an overall toxicology strategy to rapidly advance the pipeline from preclinical to clinical development and ultimately for filing license applications
• Ensures timely and accurate communication of study results and interpretation to appropriate internal drug discovery and development teams; effectively presents and contributes to governing bodies
• Design, supervise, interpret, and report in vitro and in vivo non-GLP and GLP nonclinical toxicology studies, in collaboration with study monitors and other scientists. Ensure appropriate quality of documentation for internal department studies compatible with global regulatory submission requirements.
• Writes and edits nonclinical sections for regulatory submissions
• Participates in discussions with FDA and other regulatory agencies to obtain feedback on nonclinical development programs
• Develops and maintains relationships with key scientific collaborators (internal and external)
• Maintains a current understanding of small and large molecule translational science literature and methodology, as well as the scientific literature related to the specific drug discovery projects
• May serve as a Translational Project Leader (TPL) for one or more research pipeline projects or lead other project sub-teams
• May provide guidance to other lower level personnel
• May contribute to the evaluation of new pipeline opportunities through close collaboration with the Business Development group
• May participate on departmental or company initiatives
• PhD in Toxicology, Pharmacology, or other Biological Science required with 5-8 years of industry experience in toxicology supporting drug discovery research and development
• Experience progressing biologic-based and/or small molecule drug candidate(s) through preclinical development with successful achievement of drug candidate INDs and/or BLAs/NDAs/MAAs
• Understanding of CMC, QA, regulatory and clinical, stages to guide preclinical activities setting up products for success at later stages.
• Experience with broad therapeutic modalities desirable. Experience with metabolic and genetic disease targets desirable.
• Experience in working as a PI with external CROs with timely delivery of clear and accurate well written study findings.
• Experience in designing, monitoring and interpreting nonclinical toxicology/research studies
• Experience in writing nonclinical sections of regulatory documents
• Strong knowledge of nonclinical drug development and FDA and ICH guidance documents including GLP regulations is essential
• Proven ability to collaborate across departments and with outside investigators and CROs
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.