Toxicology Study Monitor

Toxicology Study Monitor

Reporting to the Sr. Director, Toxicology in our Non-Clinical Group, you will be responsible for the management and oversight of contract research organization (CRO) work including contributions to study protocols and review of study data, coordinating with internal and external teams to maintain timelines, and QC’ing, editing, and reviewing of nonclinical reports and nonclinical sections of regulatory submissions.  This role will give you the opportunity to grow within the position to take on greater scientific responsibilities for conducted studies.

Good things are happening at Omeros!

Come join our Non-Clinical Toxicology Team!

Who is Omeros?

Omeros is a 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. 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.

Essential Duties & Responsibilities:

• Contract research organization (CRO) management and oversight:
  • Obtaining price quotes, compiling list of differences in services/deliverables/timelines/invoicing and reconciliation with Omeros budgets
  • Ensuring the contracts are in place, including ensuring all required information is captured in quotes
  • Submission of purchase requisitions
  • Keep detailed study timelines
  • Track invoicing of study components
  • Coordinate with internal and external teams to ensure timelines are met
  • Protocol preparation
    • Reviewing draft protocol to ensure consistent with outline, intentions, reviewing for areas of potential cost reduction
    • Compiling comments, ensuring review and incorporation into document
  • Data analysis
    • Prism graphs, figures, tables, slides for internal discussions and/or presentations
• Study reports and nonclinical sections of regulatory submissions
  • Editing, reviewing, and QC of study reports, sub-reports, and nonclinical sections of regulatory submissions for content, quality, accuracy, consistency, consistency with expectations of regulators, assistance with formatting
  • Compile and tabulate data
• Travel for study monitoring

Education, Experience, Skills, and Knowledge Required:

• BS/MS in a biological science or a related field
• A minimum of 3 years of experience conducting/monitoring GLP‑compliant toxicology studies in a biotech/pharma environment or CRO
• Good understanding of scientific principles and design of scientific studies
• Familiarity with nonclinical regulatory documents
• Document review and editing skills
• Skilled in computer applications such as MS word, Excel and PowerPoint
• Experience with creating Prism graphs, figures, tables, and slides
• Excellent verbal and written communication skills

Behavioral Competencies Required:

• Ability to build and maintain positive relationships with management, peers, and subordinates and external partners 
• Excellent organizational skills
• Integrity
• Display strong independent analytical and problem-solving abilities/skills
• Attention to detail and ability to multitask
• Display the ability to be creative and innovative

Other Requirements:

• Travel will be involved for study monitoring

Physical Demands and Work Environment Required:

• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 20 lbs. 
• May encounter prolonged periods of sitting
• This position requires working with and near hazardous material

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.