Non-Clinical Toxicology Study Coordinator
Omeros has an opportunity for a Toxicology Study Coordinator. Reporting to the Director, Toxicology, you will be responsible for the management and oversight of contract research organization (CRO) work, coordinating test article supply, drafting/editing SOP’s, and QC, editing and review of regulatory submissions for nonclinical sections.
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 a highly talented group and help shape the future of Omeros!
What will your responsibilities be?
Your specific job responsibilities will include:
- Contracting activities such as price quotes, preparing contracts, the preparation and submission of purchase requisitions and processing of invoices, and CRO scheduling and timeline updates
- Coordinating test article supply and tracking stability testing to support each toxicology study
- Protocol preparation and review
- Scientific oversight of nonclinical studies and study monitoring, including travel for monitoring visits
- Graphing, reporting (figures and table creation) and slide preparation for internal discussions and/or presentations as well as compiling and QC of nonclinical data tables
- Editing, reviewing and QCing of reports and nonclinical sections of regulatory submissions
- Drafting, editing and reviewing SOP’s
- Creating and overseeing new process controls
Education and experience needed:
You’ll need to have a BS or MS degree in a biological science or a related field along with a minimum of 5 years of experience conducting and/or monitoring GLP compliant toxicology studies in a biotech/pharma environment. Preferably, you’ll need to have previous experience with creating prism graphs, figures, tables, and slides.
Skills and knowledge we are seeking:
Our ideal candidate will have a strong desire to contribute to a growing, dynamic organization and be willing to jump in where needed to help move critical timeline-driven projects forward. Additionally, you will need the following skills and knowledge:
- Familiarity with nonclinical GLP study documents
- Document review editing skills
- Microsoft Office (MS Word, Excel, PowerPoint, etc.) skills; Prism or other statistical or scientific applications skills are a plus
- Excellent written and verbal communication skills
- Ability to build and maintain positive relationships with management, peers and external customers
- Ability to work independently and within a team environment
- Excellent organizational skills
- Display strong independent analytical and problem-solving skills
- Detail orientation
- Demonstrated ability to be creative and innovative
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.