Senior Director or Executive Director, Toxicology

Role Summary

We are seeking an experienced nonclinical toxicologist with small molecule drug development experience to join the Preclinical Development team at Kymera Therapeutics. The successful candidate will be responsible for overseeing the strategy, design, analysis, interpretation and reporting of Toxicology and Safety Pharmacology data for discovery and development teams. In addition, the individual will work with early discovery teams to develop preclinical safety strategies for new targets and support for programs in lead optimization and preclinical development.

Responsibilities

• Provide expert nonclinical safety support, guidance, and strategy for Kymera‚Äôs degrader projects, ranging from discovery programs to advanced clinical programs
• Act as the key nonclinical safety representative on cross-functional development teams contribute nonclinical safety-related scientific and regulatory expertise to drive integrated program decision-making.
• Develop nonclinical safety strategies and plans for programs in all stages of drug development
• Oversee toxicology and safety pharmacology studies at multiple Contract Research Organizations
• Design and execute GLP, non-GLP, investigative, and in vitro studies
• With internal Study Monitor support, oversee toxicology studies for appropriate conduct, accuracy, and timely execution; review draft protocols and reports and ensure quality submission-ready documents for regulatory authorities
• Internal and external communication
• Prepare verbal and written summaries for internal discussions. Work with the Preclinical Development team to develop optimal strategies to address specific safety issues and partner with project teams
• Lead authorship of toxicology and/or safety pharmacology sections of various regulatory documents (e.g., pre-IND briefing documents, IND, IBs etc.)
• Represent company at meetings with regulatory agencies
• Present summary data to project teams and Kymera senior leadership
• Leadership
• Provide leadership and mentorship to junior toxicology or preclinical staff as the team grows; foster a culture of scientific excellence

Qualifications

• PhD in Toxicology or Pharmacology, DVM, or related field; DABT or ERT certification preferred, but not required
• 12+ years of experience in the biopharma industry in a Toxicology or Pathology role including ‚â• 5 years supporting small molecule project teams leading preclinical development strategy for IND-through-Phase II programs
• Experience with EMA and FDA CTA/IND submissions and regulatory interactions
• Experience partnering with internal stakeholders and colleagues to ensure comprehensive preclinical safety approaches are developed as part of the program strategy
• Strong verbal and written communication skills with the ability to influence and present to executive leadership and external stakeholders, including regulatory agencies
• Experience working with outsourced studies
• Ability to perform in fast-paced and dynamic environment

Skills

• Nonclinical safety strategy development
• Toxicology and safety pharmacology study design and oversight
• Regulatory-submission preparation (IND/CTA/IBs)
• Cross-functional collaboration and communication
• Leadership and mentorship

Education

• PhD in Toxicology or Pharmacology, DVM, or related field

Additional Requirements

• None specified