Executive Director, Nonclinical Safety (Pathology & Toxicology)

Company: Side Hamburg
Location: Boston
Posted on: May 20, 2025

Job Description:

Executive Director, Nonclinical Safety (Pathology & Toxicology)Nimbus has an outstanding opportunity for a Toxicologic Pathologist with deep small molecule expertise to lead our Nonclinical Safety function. This individual will play a dual role-setting the strategic direction while also being actively engaged in hands-on discovery and clinical development program execution. The Executive Director, Nonclinical Safety will manage one full-time employee, external consultants, and CRO partnerships to support Nimbus's portfolio of small molecule programs. This exciting opportunity will make a significant impact within a nimble biotech environment, where cross-functional collaboration and scientific excellence drive success. You will report to our Senior Vice President, Nonclinical Sciences.In This Role, You Will:

• Serve as the lead for Nonclinical Safety (Pathology & Toxicology), shaping the strategy and execution of nonclinical safety assessments for Nimbus's pipeline.
• Provide comprehensive support for nonclinical studies, including but not limited to possible pathology peer reviews, interpretation of all nonclinical study data/findings, and guiding study designs, execution, and reporting to support regulatory submissions.
• Manage and provide scientific leadership to the internal staff, oversee consultants, and work closely with external CROs to ensure high-quality toxicology assessments.
• Work closely with Discovery, Nonclinical Sciences, Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals.
• Partner with Regulatory Affairs to develop and execute nonclinical safety strategies for regulatory filings worldwide.
• Balance strategic leadership with direct involvement in nonclinical safety study conduct including but not limited to design, monitoring, interpretation, issue resolution, and reporting.
• Identify and proactively address potential safety risks in early and late-stage programs, ensuring scientific rigor and regulatory alignment.
• Select, manage, and oversee toxicology and pathology vendors to ensure high-quality study execution.
• Ensure compliance with global nonclinical toxicology and safety studies according to regulatory guidelines and internal timelines and goals.These Qualifications Will Help This Role Be Successful:
  • DVM and/or PhD with specialty training and experience in Toxicologic Pathology.
  • 18+ years of industry experience in toxicologic pathology within biotech or pharmaceutical settings.
  • Expertise in small molecule drug development, including nonclinical safety assessments.
  • Strong experience designing, overseeing, and interpreting GLP and non-GLP toxicology studies.
  • Demonstrated ability to lead and manage internal team members, consultants, and CRO partnerships.
  • Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities.
  • Experience responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs.
  • Expertise with the design and management of safety pharmacology and toxicology studies (GLP and non-GLP) supporting nonclinical and clinical development programs.
  • Excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams.
  • Proven ability to thrive in a fast-paced, biotech environment.Join Nimbus. We are making a difference and you can too.At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success.
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Keywords: Side Hamburg, East Providence , Executive Director, Nonclinical Safety (Pathology & Toxicology), Executive , Boston, Rhode Island