Nimbus has an outstanding opportunity for an exceptional Senior Director of Nonclinical Safety to join our rapidly-growing team. 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 SVP and Head of Nonclinical Development.
In this role, you will:
- Develop the strategic nonclinical development plan in collaboration with stakeholders
- Ensure execution of nonclinical toxicology and safety studies to support company timelines and goals
- 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 filing, and clinical development of new small molecule drug entities
- Represent Nonclinical Safety at cross-functional project teams
- Oversee the design and management of safety pharmacology and toxicology studies (GLP and non-GLP) supporting preclinical and clinical development programs
- Oversee the selection and management of consultants and CROs to support nonclinical safety studies for development programs
- Manage non-clinical 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
- Review nonclinical safety study reports to support regulatory filing including IND, IND annual updates, IB, as well as relevant sections to support US and International filings
- 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
- Ensures completion of nonclinical safety studies to support Company timelines and goals
These Qualifications Will Help This Role Be Successful
- PhD in Toxicology/Pathology or DVM and 10+ years of toxicology experience in the pharmaceutical industry or Master’s in Toxicology/Pathology or DVM and 15+ years of experience
- Experience in nonclinical GLP toxicology and safety assessment of small molecules from IND submission through NDA approval
- 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
A Snapshot of Nimbus
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.
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.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
Join Nimbus. We are making a difference and you can too.
Nimbus is an equal opportunity employer. We do not discriminate on the basis of 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.