Principle Scientist/Associate Director, Toxicology
Omeros is seeking a Principal Scientist / Associate Director, Toxicology 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.
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.
The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
Come and join our highly talented Nonclinical Team and help shape the future of Omeros!
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 multifunctional 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
Education and experience needed:
You’ll need to have a PhD in Toxicology or a related field with a minimum of 4 years of industry experience (or a BS/MS with a minimum of 8+ years of experience) as part of a drug development project team. 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
Skills and knowledge we are seeking:
You’ll need to have following skills and knowledge:
· 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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.