Principal Scientist, Toxicology

Location
Seattle, WA, United States
Posted
Apr 10, 2021
Ref
1781
Hotbed
BioForest
Required Education
Other
Position Type
Full time
Principal Scientist or Associate Director - Toxicologist

Omeros is seeking a Toxicologist at either a Principal Scientist or Associate Director level who has experience designing, planning and executing nonclinical development plans for both small molecules and biologics.

Reporting to the Sr. Director, Toxicology, you will be responsible for conducting, interpreting and reporting nonclinical animal studies outsourced to contract research organizations (CROs), as well as serving as the Toxicology representative to internal Omeros multidisciplinary project teams. Expert knowledge of GLP regulations and regulatory guidelines is essential as you'll serve as the primary author of the nonclinical sections of both US and international regulatory dossiers supporting clinical trials and eventual marketing applications.

Come join our highly talented Nonclinical Team and help shape the future of Omeros!

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

What will your responsibilities be?

Your specific job responsibilities will include:

  • Applying a broad understanding of toxicology, pharmacology, ADME, and knowledge of applicable regulatory guidelines to the design of appropriate toxicology studies and development plans
  • Providing creative approaches to expedite nonclinical development strategies
  • Providing a critical review of toxicology study protocols, data and study reports
  • Serving as the Toxicology representative on multi-functional project teams supporting discovery and development phase projects
  • Contributing to the preparation of high-quality regulatory documents supporting global clinical development and marketing authorizations
  • Effectively communicating toxicology study results to project teams and senior level management
  • You'll need to have a PhD in Toxicology or a related field with a minimum of 4 years of industry experience as part of a drug development project team; a BS/MS will be considered. Additionally, you'll need the following:
  • Substantial nonclinical development experience at a pharmaceutical or biotechnology company
  • Experience in designing, monitoring and interpreting nonclinical toxicology/safety pharmacology studies
  • Experience in writing nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.) and direct interactions with worldwide regulatory agencies
  • Certification by the American Board of Toxicology (DABT) is highly desired
  • A strong scientific knowledge of toxicology, with expert knowledge in one or more specialty areas of the discipline
  • A strong working knowledge of US and international regulatory guidelines
  • Familiarity with drug development strategies for both small molecules and biologics
  • Ability to be proficient and work independently and in cross-functional team settings, building productive collaborations, managing conflict, multi-tasking, and prioritizing
  • Excellent written and verbal communication skills
  • Demonstrated ability to build and maintain positive relationships with management, peers and external customers
  • Strong sense of personal responsibility, creativity and integrity
This is an opportunity for you to be a key member of a collaborative group contributing your talent and expertise to a company that has an exciting pipeline. If you have the knowledge, skills and experience we are looking for, we'd love to hear from you!

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.