Arvinas is a clinical-stage biopharmaceutical company leading the way in targeted protein degradation therapeutics. Arvinas is the first company to focus solely on protein degradation and its platform technology is the most advanced in the field. Since its founding in 2013, Arvinas’ PROTAC® Discovery Engine has been driving the most significant breakthroughs in the industry. Arvinas’ pipeline encompasses a range of validated and undruggable targets in oncology, immuno-oncology, and neuroscience. This includes three clinical-stage programs: bavdegalutamide (ARV-110) and ARV-766, which are being developed as potential treatments for men with late-line metastatic castrate-resistant prostate cancer, and ARV-471, which is being developed as a potential treatment for patients with breast cancer.
#TeamArvinas is made up of more than 350 passionate and curious employees, whose diverse thoughts and perspectives are highly valued. Arvinas employees embrace the freedom to pursue innovation, think creatively, and give back. They are driven by the company’s values and purpose – to improve the well-being of patients and families impacted by the devastating diseases Arvinas is working to treat. It’s an exciting time to be in drug development and it’s an exciting time to be at Arvinas. But don’t just take our word for it – here’s what Arvinas employees are saying. For more information, please visit www.arvinas.com.
The toxicologist will be a member of the Nonclinical Science group and will be responsible for executing overall toxicology strategy and overseeing the design and conduct of toxicity studies of Arvinas' various preclinical and clinical assets. For individual projects, the incumbent will contribute various aspects of toxicology assessments, including the evaluation of target safety risk assessment, will design and execute the IND-enabling safety assessment strategy, and will ensure continuing toxicology safety support throughout clinical development, as well as NDA submission and any postmarking commitments.
The incumbent may be based at our headquarters location in New Haven, CT or in a remote role based within the U.S.
Key responsibilities of this role include, but are not limited to:
- Serve as a member of the Nonclinical Science Team responsible for toxicology assessment for designated projects
- Ensure planning and timely execution of toxicology studies and delivery of key toxicology data to meet key project milestones, and for incorporation of that data into key regulatory documents for submission
- Serve as the company sponsor for the conduct of toxicology studies including study designs, protocol generation, study conduct, data communication with various stakeholders, report preparation, review, finalization and archiving. Coordinate with other internal functions including nonclinical formulation, formulation analysis, DMPK, Regulatory, etc.
- Conduct monitoring and due diligence visits to CROs for key GLP studies
- Participate in the preparation of relevant toxicology sections of regulatory documents, such as Investigational New Drug (IND), DSUR, Investor Brochure (IB), New Drug Application (NDA), and other relevant regulatory documents as needed.
- Represent toxicology on company-wide drug discovery and development teams.
- A minimum of 5+ years of relevant industry experience.
- Knowledge of and experience with GLP regulations for toxicology studies.
- Knowledge of various types of toxicology studies and demonstrated ability to plan and, in coordination with CROs, to execute studies in a timely, high quality and regulatory-compliant manner
- Experience as a toxicology representative on discovery or development teams and ability to communicate toxicology results to internal stakeholders
- Working knowledge of regulatory, toxicology and ICH guidelines for drug development.
- Experience in authoring and reviewing toxicology study reports and toxicology-related aspects of regulatory documents.
- Previous experience in toxicology strategy for preclinical and clinical programs in oncology, neurodegenerative diseases, and immuno-oncology is desired
- Ph.D. in toxicology or other related scientific disciplines
Arvinas is proud to offer a competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, and much more. To learn more about Arvinas, please visit www.arvinas.com
Arvinas is an Equal Opportunity employer