Job Description

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:

1. Serve as the lead for Nonclinical Safety (Pathology & Toxicology), shaping the strategy and execution of nonclinical safety assessments for Nimbus's pipeline.
2. 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.
3. Manage and provide scientific leadership to the internal staff, oversee consultants, and work closely with external CROs to ensure high-quality toxicology assessments.
4. Work closely with Discovery, Nonclinical Sciences, Clinical Development, and Regulatory to integrate nonclinical safety findings into overall program strategy and goals.
5. Partner with Regulatory Affairs to develop and execute nonclinical safety strategies for regulatory filings worldwide.
6. Balance strategic leadership with direct involvement in nonclinical safety study conduct including but not limited to design, monitoring, interpretation, issue resolution, and reporting.
7. Identify and proactively address potential safety risks in early and late-stage programs, ensuring scientific rigor and regulatory alignment.
8. Select, manage, and oversee toxicology and pathology vendors to ensure high-quality study execution.
9. 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:

1. DVM and/or PhD with specialty training and experience in Toxicologic Pathology.
2. 18+ years of industry experience in toxicologic pathology within biotech or pharmaceutical settings.
3. Expertise in small molecule drug development, including nonclinical safety assessments.
4. Strong experience designing, overseeing, and interpreting GLP and non-GLP toxicology studies.
5. Demonstrated ability to lead and manage internal team members, consultants, and CRO partnerships.
6. Deep understanding of regulatory requirements for nonclinical safety assessments, including experience with FDA, EMA, and other global health authorities.
7. Experience responding to regulatory questions including discussion documents for various Health Authorities in support of discovery and development programs.
8. Expertise with the design and management of safety pharmacology and toxicology studies (GLP and non-GLP) supporting nonclinical and clinical development programs. More specifically, experience with management of nonclinical safety studies conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, review of data and draft study reports, completion of contract milestones, study close-out and alignment of nonclinical safety evaluations with drug development efforts and priorities.
9. Excellent communication and leadership skills, with the ability to translate complex scientific findings into actionable insights for cross-functional teams.
10. Proven ability to thrive in a fast-paced, biotech environment.

A Snapshot of Nimbus

Our Science

At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we've built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.

Our Culture

Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.

Our Company

Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Boston, Massachusetts. Learn more about us by going to

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. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates. #J-18808-Ljbffr

Job Tags

Full time, Contract work, Worldwide,

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