Senior Scientist I/II, Nonclinical Sciences

Location
Novato, CA
Posted
Jul 31, 2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Why Join Us?

To be a hero for our rare disease patients

Ultragenyx is a biopharmaceutical company committed to bringing to patients novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy 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. 

Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.

Come join our team during this exciting time of growth and opportunities!

Position Summary

ultracurious – Apply your biggest ideas in courageous ways

The Senior Scientist I/II, Nonclinical Sciences is the scientific lead for nonclinical studies (non-GLP and GLP) conducted internally or externally for Ultragenyx’s drug development programs for all phases of development.  The Senior Scientist I/II partners closely with internal stakeholders, other scientists, study managers, Contract Research Organizations (CROs) and academic institutions in order to design, execute, monitor, interpret, and report studies.  The Senior Scientist I/II prioritizes workflow in alignment with program and project timelines and provides Sponsor oversight.  This position reports into the Pharmacology and Toxicology organization.  

Responsibilities including, but not limited to:

  • Work closely with Pharmacology and Toxicology, Research, Development, Regulatory and Clinical Development to develop and execute an overall pharmacology and toxicology strategy to rapidly advance the pipeline from preclinical to clinical development and ultimately for filing license applications
  • May have a supervisory role and/or lead a program. Serve as a departmental representative on project teams
  • Ensures timely and accurate communication of study results and interpretation to appropriate internal drug discovery and development teams; effectively presents to governing bodies and contributes to discussions and facilitates decision making
  • Design, conduct or supervise, analyze/interpret, and report in vitro, ex vivo, and in vivo non-GLP (or GLP studies conducted at CROs) nonclinical pharmacology, PK/PD, and/or toxicology studies, in collaboration with study monitors and other scientists. Ensure appropriate quality of documentation and record keeping for internal department studies compatible with global regulatory submission requirements. 
  • Ensure compliance with study protocols, GLP regulations (as applicable) and department work instructions.  Adhere to animal welfare and IACUC guidelines and foster animal 3Rs principles and intent
  • Write and review nonclinical study documents, manuscripts, and other scientific and regulatory documents.  May contribute to regulatory submissions
  • May participate 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)
  • Maintain 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 participate on departmental or company initiatives

Technical Requirements & Skills:

  • Normally requires a PhD in toxicology, pharmacology, or other biological science and 5 to 10+ years related experience (may include post-doctoral experience) or 12 to 20+ years related experience (BA/BS/MS), depending on level.  
  • Experience in designing, conducting and interpreting nonclinical pharmacodynamics, pharmacokinetics, and/or toxicology studies and experiments
  • Strong knowledge of nonclinical drug development, FDA and ICH guidances, and GLP regulations
  • 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 is desirable
  • Understanding of CMC, QA, regulatory and clinical stages to guide preclinical activities setting up products for success at later stages
  • Experience in working as a PI with external CROs with timely delivery of clear and accurate well written study findings
  • Experience in writing nonclinical sections of regulatory documents
  • Proven ability to collaborate across departments and with outside investigators and CROs
  • Excellent critical thinking and analytical skills
  • Excellent communication skills, both written and verbal
  • Organized and skilled in managing and prioritizing multiple responsibilities, tasks, and projects
  • Team oriented; seeks collaboration and is inclusive; capable of working collaboratively across all levels and organizations

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 tohr@ultragenyx.com.