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Nonclinical Toxicology Study Monitor

Employer
Omeros Corporation
Location
Seattle
Start date
Jun 25, 2019

View more

Discipline
Science/R&D, Toxicology
Required Education
Bachelors Degree
Position Type
Full time

Job Details

Omeros has an opportunity for a Toxicology Study Monitor. Reporting to the Sr. Director, Toxicology, you will be responsible for the management and oversight of contract research organization (CRO) work and QC 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
  • Compiling data (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
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 graphs, figures, tables, and slides.

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
  • Familiarity with Good Laboratory Practices (GLP)
  • Document review editing skills
  • Microsoft Office (MS Word, Excel, PowerPoint, etc.) skills; Prism or other 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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Company info
Website
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
Washington
98119
US

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