Scientist, Toxicology

Company: Horizon Therapeutics
Location: Oakland
Posted on: June 24, 2022

Job Description:

Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs.

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.

Keywords: Horizon Therapeutics, Oakland , Scientist, Toxicology, Other , Oakland, California