Nimbus Therapeutics, Inc.
Director / Senior Director, Nonclinical Safety
Nimbus Therapeutics, Inc., Oklahoma City, Oklahoma, United States,
Senior Director, Nonclinical Safety (Toxicology)
Nimbus has an outstanding opportunity for a Senior Director of Nonclinical Safety (Toxicology) to join our growing organization. Serving as the function head, this role will lead the nonclinical safety strategy and execution for programs across discovery, nonclinical, and clinical stages. This role will also oversee aspects of investigative toxicology, strategic review and interpretation of all non-GLP and GLP toxicology studies, the nonclinical safety budget, and collaborate with team members, project teams, and external partners to ensure alignment and drive excellence in nonclinical safety practices. You will report to our Senior Vice President of Nonclinical Sciences.In This Role, You Will:Develop the strategy of nonclinical development plan in collaboration with internal and external stakeholdersPropose and implement project-specific nonclinical toxicology study design (non-GLP and GLP), and ensure execution of toxicology studies to support company timelines and goalsOversee the selection and management of consultants and CROs. 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, demonstrate the ability to interpret the data, review draft study reports, completion of contract milestones, study close-out and alignment of nonclinical safety evaluations with drug development efforts and priorities.Prepare all nonclinical safety-relevant documents to support regulatory filing including IND, IND annual updates, IB, and DSUR, as well as briefing books for US, EU, Japan, and International regulatory meetings and filingsRespond with scientifically robust rationale to questions from US FDA, EU, Japan, and other health authorities in support of development programsAs a study monitor, direct and oversee nonclinical toxicology studies including but not limited to genetic toxicology, safety pharmacology, general toxicology, and development and reproductive toxicology studies supporting nonclinical and clinical development programsEnsure compliance with global nonclinical toxicology studies as per regulatory guidelinesCollaborate with CMC, Program & Portfolio Management, Clinical, 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 entitiesProvide leadership and management support that can build and inspire our team and drive collaboration and innovationRepresent Nonclinical Safety at cross-functional project and safety teams as well as leadership teams/reviewsThese Qualifications Will Help This Role Be Successful:PhD and/or DVM in Toxicology or related health discipline with 15+ years of toxicology experience in the pharmaceutical and/or biotechnology industry. DABT or DACVP/FIATP certification is valued but not requiredExperience in nonclinical GLP toxicology and safety assessment of Small Molecule Drugs from IND/CTA submission through various clinical development phases. Experience with NDA/MAA submission is a plusDemonstrate knowledge and full understanding of GLP regulatory requirements and providing responses to the FDAStrong leadership competencies and management experience, including selecting CROs and overseeing the quality of relationshipsAbility and interest in leading project team member(s)Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teamsAttention to detail quality and complianceAbility to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environmentJoin 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
Nimbus has an outstanding opportunity for a Senior Director of Nonclinical Safety (Toxicology) to join our growing organization. Serving as the function head, this role will lead the nonclinical safety strategy and execution for programs across discovery, nonclinical, and clinical stages. This role will also oversee aspects of investigative toxicology, strategic review and interpretation of all non-GLP and GLP toxicology studies, the nonclinical safety budget, and collaborate with team members, project teams, and external partners to ensure alignment and drive excellence in nonclinical safety practices. You will report to our Senior Vice President of Nonclinical Sciences.In This Role, You Will:Develop the strategy of nonclinical development plan in collaboration with internal and external stakeholdersPropose and implement project-specific nonclinical toxicology study design (non-GLP and GLP), and ensure execution of toxicology studies to support company timelines and goalsOversee the selection and management of consultants and CROs. 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, demonstrate the ability to interpret the data, review draft study reports, completion of contract milestones, study close-out and alignment of nonclinical safety evaluations with drug development efforts and priorities.Prepare all nonclinical safety-relevant documents to support regulatory filing including IND, IND annual updates, IB, and DSUR, as well as briefing books for US, EU, Japan, and International regulatory meetings and filingsRespond with scientifically robust rationale to questions from US FDA, EU, Japan, and other health authorities in support of development programsAs a study monitor, direct and oversee nonclinical toxicology studies including but not limited to genetic toxicology, safety pharmacology, general toxicology, and development and reproductive toxicology studies supporting nonclinical and clinical development programsEnsure compliance with global nonclinical toxicology studies as per regulatory guidelinesCollaborate with CMC, Program & Portfolio Management, Clinical, 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 entitiesProvide leadership and management support that can build and inspire our team and drive collaboration and innovationRepresent Nonclinical Safety at cross-functional project and safety teams as well as leadership teams/reviewsThese Qualifications Will Help This Role Be Successful:PhD and/or DVM in Toxicology or related health discipline with 15+ years of toxicology experience in the pharmaceutical and/or biotechnology industry. DABT or DACVP/FIATP certification is valued but not requiredExperience in nonclinical GLP toxicology and safety assessment of Small Molecule Drugs from IND/CTA submission through various clinical development phases. Experience with NDA/MAA submission is a plusDemonstrate knowledge and full understanding of GLP regulatory requirements and providing responses to the FDAStrong leadership competencies and management experience, including selecting CROs and overseeing the quality of relationshipsAbility and interest in leading project team member(s)Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teamsAttention to detail quality and complianceAbility to navigate, problem-solve, execute, and lead in a dynamic, fast-paced and evolving environmentJoin 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