Senior Director/Director of Toxicology

Position Description:

The Sr. Director/Director of Toxicology is responsible for overseeing the overall strategy, design, analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for Discovery and Development programs. In addition, s/he will liaise with Research and Development colleagues to develop overall Safety Pharmacology and Toxicology Development Strategies, and represent Preclinical Development on Discovery and Development teams.

In this role you will:

• Design, implement, drive, and oversee toxicology strategies for portfolio assets
• Work with internal teams and external partners to execute on development program team objectives

• Contribute to development program strategy, study execution, data review/analysis, study reports, protocol preparation and regulatory document preparation; write and review non-clinical toxicology summary documents
• Oversees vendors and consultants as appropriate to execute on toxicology studies
• Will report findings and advise the Leadership Team on Preclinical Safety of development candidates
• Lead authorship for toxicology sections for all regulatory documents. Lead the resolution of toxicology-related queries from drug regulatory agencies, writing and reviewing responses to regulatory on toxicology-related queries

We are looking for people who have:

• PhD in Toxicology, Pharmaceutical Sciences, DVM or related field is required
• DABT certification is highly desired
• A minimum of 10 years' experience in the life science industry in a Toxicology role and proven track record of conducting drug safety assessment studies, and ability to make sound risk assessments and represent toxicology perspectives on project teams and with external partners
• Direct experience developing the toxicology strategy and data package supporting the clinical development of protein biologics
• Track record of toxicology leadership on multiple development programs at early and late stages of development
• Firm understanding of pharmacokinetics and modeling human dosing
• Experience with EMA and FDA CTA/IND and BLA submissions and regulatory interactions
• Experience partnering with DMPK, Regulatory Affairs, Clinical, CMC and Translational Science colleagues to ensure comprehensive Toxicology approaches are developed as part of the program strategy
• Extensive experience working with strategic outsourcing and study coordination
• Ability to perform in fast-paced, dynamic, constantly evolving environment
• Excellent communication and organizational skills and attention to detail
• Strong time management skills; ability to prioritize multiple tasks efficiently