Senior Director or Executive Director, Toxicology

Role Summary

Senior Director or Executive Director, Toxicology role focused on nonclinical safety strategy and execution for Kymera’s degrader programs, spanning discovery to advanced clinical development.

Responsibilities

• Provide expert nonclinical safety support, guidance, and strategy for Kymera‚Äôs degrader projects, from discovery through advanced clinical programs.
• Act as the key nonclinical safety representative on cross-functional development teams and contribute scientific and regulatory expertise to drive integrated program decision-making.
• Develop nonclinical safety strategies and plans for programs at 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; review protocols and reports to ensure submission-ready documents for regulatory authorities.
• Prepare verbal and written summaries for internal discussions; collaborate with the Preclinical Development team to address safety issues and partner with project teams.
• Lead authorship of toxicology and/or safety pharmacology sections of regulatory documents (e.g., pre-IND briefing documents, IND, IBs).
• Represent the company at meetings with regulatory agencies and present summary data to project teams and Kymera senior leadership.
• Provide leadership and mentorship to junior toxicology or preclinical staff; 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 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 to develop comprehensive preclinical safety approaches as part of program strategy.
• Strong verbal and written communication skills; ability to influence and present to executive leadership and regulatory agencies.
• Experience working with outsourced studies.
• Ability to perform in a fast-paced and dynamic environment.

Skills

• Nonclinical safety strategy development
• Toxicology and safety pharmacology study design and oversight
• Regulatory submission preparation and interactions
• Cross-functional leadership and mentorship
• External communications with regulatory bodies

Education

• PhD in Toxicology or Pharmacology, DVM, or related field (as applicable per role requirements)

Additional Requirements

• Travel or physical demands not specified as essential in the provided content.