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.
The department of Pharmacology & Toxicology at Ultragenyx is looking for an Associate Director/Senior Scientist, Pharmacology 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 Executive Director of Nonclinical Research. The Associate Director/Senior Scientist, Pharmacology will be a part of an innovative department where scientists utilize cutting edge strategies and technologies to explore and help optimize the R&D processes. The incumbent will be responsible for devising preclinical in vivo pharmacology program strategy plans and ensuring their execution to help progress Ultragenyx’s pipeline. The incumbent will also be responsible for the preparation of regulatory documents. The incumbent is expected to actively and energetically collaborate across the company. The Associate Director/Senior Scientist, Pharmacology may also have management responsibilities for other scientists and/or technical staff.
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:
• Identifies, designs, plans, ensures model development / validation / readiness and successfully executes the appropriate in vivo model assays to answer key biological / pharmacological questions, facilitate program progression and enable data-driven decision making.
• Effectively collaborates with other functions within the research, translational, regulatory and clinical development departments to develop a focused and appropriate pharmacology strategy to rapidly advance assets from preclinical to clinical development
• Ensures scientific rigor, the use of appropriate biostatistical analysis and the generation of high quality data to support decision-making on individual compounds and programs.
• Communicates plans, timelines, data, interpretation and proposed next steps to relevant teams and governing bodies effectively and accurately
• Authors in vivo pharmacology protocols and reports. Writes, reviews and edits nonclinical sections for regulatory submissions
• Participates in project core team meetings as a key representative. May serve as a Translational Project Leader (TPL) for one or more research pipeline projects or lead other project sub-teams
• Establish linkage between MOA, animal model and human diseases and develop biomarker strategies for integration and translation into clinical development plans
• 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 relevant to the specific projects s/he works on
• May provide guidance to other lower level personnel
• May participate in the identification and implementation of pharmacodynamic and patient selection biomarkers to support the advancement of preclinical programs into the clinic and collaborate with Clinical group to define therapeutic opportunities and select the optimal clinical strategy for each program
• May review and contribute to scientific due diligence for in-licensing opportunities.
• May participates in discussions with FDA and other regulatory agencies to obtain feedback on nonclinical development programs
• PhD in Pharmacology, or other relevant Biological Science required with 5-8 years of industry experience driving in vivo pharmacology activities in support of drug discovery, research and development
• Strong attention to detail and exceptional interpersonal, organizational, writing and communication skills
• Experience with in vivo models in multiple species (rodent and non-human primates)
• Experience working with multidisciplinary teams toward common project goals and the ability to successfully collaborate and work by influencing others in a matrixed environment by promoting creative problem solving, clear decision-making and accountability
• Successful history of progressing biologics- and/or small molecule drug candidate(s) through preclinical development leading to successful INDs
• Experience working with external providers such as contract research organizations and academic specialty laboratories
• Track-record in designing, monitoring and interpreting nonclinical pharmacology studies and conducting hypothesis based experiments.
• Experience with broad therapeutic modalities desirable. Experience with CNS, hematology, muscle, metabolic, and/or genetic diseases highly desirable.
• Experience in writing/reviewing/editing protocols, reports and nonclinical sections of regulatory documents
• 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.