Job Description
Responsibilities:
- Will function as a nonclinical safety representative and toxicologist between Horizon and contract research organizations (CROs) for non-GLP and GLP studies
- Experienced with in vivo toxicology studies and knowledgeable of ICH guidances, GLPs, IACUC, 3Rs
- Facilitate study contracts, request quotes with CROs
- Manage study monitoring aspects of toxicology studies with CRO partners to ensure timely delivery of actionable nonclinical data (data, reports and SEND) to project teams with oversight
- Cross functionally collaborate with internal departments (analytical, manufacturing, formulations, and pharmacokinetics) to facilitate toxicology study planning and initiation
- Summarize and communicate nonclinical safety data to internal and external functions in presentations
- Authorship of nonclinical safety documents for regulatory submissions (INDs, IBs) with oversight using MS word, Excel and compliance software as appropriate.
- Travel as needed to monitor toxicology studies
Qualifications and Skills Required:
- BS, MS degree in a relevant life science discipline or a PhD in Toxicology discipline
- 7+ (Bachelors), 4+ (Masters), 2+ (PhD) years experience in nonclinical safety at a toxicology CRO or in industry partnering with toxicology CROs
- Ability to travel up to 30%, potential to be international as required
- In-depth knowledge of Good Laboratory Practices, FDA, and ICH guidelines
- Proficient in Microsoft Office and Graphpad Prism
- Professional, proactive demeanor
- Excellent written and verbal communication skills
Horizon Core Values & Competencies:
Growth
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
Accountability
- Drives Results
- Ensures Accountability
- Decision Quality
Transparency
- Courage
- Collaboration
- Instills Trust
Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.
Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.
Date Posted
08/06/2022
Views
17
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