Director/Senior Director, Nonclinical Safety
Nimbus has an outstanding opportunity for an exceptional Director / Senior Director of Nonclinical Safety to join our team at our headquarters in Boston, MA. This role will lead the safety strategy, through both preclinical and clinical stages, and direct all phases of in vivo GLP and non-GLP toxicology studies, in collaboration with study teams, CROs and consultants. The person in this role will interface with various functional groups within the company and will report to our ED of Nonclinical Safety.
In this role, you will:
- Develop the strategic nonclinical toxicology development plan for programs in development in collaboration with stakeholders
- Collaborate with CMC, Program & Portfolio Management, Clinical, Medical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND/CTA filing, and clinical development of new small molecule drug entities
- Represent Nonclinical Safety at cross-functional project teams
- Oversee the design and execution of safety pharmacology and toxicology studies (GLP and non-GLP) supporting preclinical and clinical development programs consistent with company timelines and goals
- Contribute to the selection and management of consultants and CROs to support nonclinical safety studies for development programs
- Manage 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
- Ensures completion of nonclinical safety studies to support Company timelines and goals
- Respond to questions and prepare discussions documents for the FDA to in support of development programs.
- Ensure compliance with global nonclinical toxicology and safety studies as per regulatory guidelines
These Qualifications Will Help This Role Be Successful
- PhD in Toxicology/Pathology or DVM and approximately 10 years of toxicology experience in the pharmaceutical industry or Master’s in Toxicology/Pathology or DVM and approximately 15 years of experience
- Experience in nonclinical GLP toxicology and safety assessment of small molecules from discovery through regulatory submission
- Strong leadership competencies and management experience, including selecting CROs and overseeing the quality of relationships
- Demonstrated knowledge and full understanding of GLP regulatory requirements and providing responses to the FDA
- DABT certification is preferred, but not required
- Attention to detail quality and compliance
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environment
Base salary range: $225,000 - $285,000
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, intellectually stimulating, and collaborative environment. We live by our Essential Behaviors: Elevate Your Perspective, Listen and Speak Up, Explore the Unconventional, and Leverage the Team’s Experts — 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 biotechnology company headquartered in Boston, Massachusetts. Learn more about us by going to www.nimbustx.com
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.
Skills Required
- PhD in Toxicology or Pathology, or DVM, with approximately 10 years of toxicology experience in the pharmaceutical industry
- Alternatively, Master's degree in Toxicology or Pathology, or DVM, with approximately 15 years of experience
- Experience in nonclinical GLP toxicology and safety assessment of small molecules from discovery through regulatory submission
- Strong leadership and management experience, including selecting CROs and overseeing CRO relationships
- Demonstrated knowledge of GLP regulatory requirements and experience providing responses to the FDA
- DABT certification
- Strong attention to detail, quality, and compliance
- Excellent verbal and written communication and organizational skills, with demonstrated success leading projects and interacting with cross-functional teams
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced, evolving environment
What We Do
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.
