Director of Nonclinical Safety
1 day ago
Orange Grove Bio is seeking an exceptional Director of Nonclinical Safety to join our rapidly growing team. As a key member of our organization, you will lead the safety strategy from discovery through both nonclinical and clinical stages, and direct all phases of early investigative toxicology and in vivo non-GLP and GLP toxicology studies.
Key Responsibilities:- Develop the strategy of the nonclinical development plan in collaboration with stakeholders
- Propose and implement project-specific nonclinical toxicology study design (non-GLP and GLP), and ensure execution of toxicology studies to support company timelines and goals
- As 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 programs
- Oversee 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
- Ensure compliance with global nonclinical toxicology studies as per regulatory guidelines
- Prepare all nonclinical safety-relevant documents to support regulatory filings
- PhD or DVM in Toxicology/Pathology with 10 years, or MS in Toxicology/Pathology with 15 years of toxicology experience in the pharmaceutical and/or biotechnology industry
- Experience in nonclinical GLP toxicology and safety assessment of Small Molecule Drugs from IND submission through various clinical development phases
- Experience with NDA submissions is plus
- Demonstrate knowledge and full understanding of GLP regulatory requirements and providing responses to the FDA
- Excellent verbal and written communication and organizational skills required with demonstrated success in leading projects and interacting with cross functional teams
- Strong leadership competencies and management experience, including selecting CROs and overseeing the quality of relationships
- Attention to detail quality and compliance
- Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced, and evolving environment
- Competitive salary range: $180,000 - $220,000
- SHRM membership reimbursement
- Discretionary annual bonus
- Unlimited paid time off
- Comprehensive benefits package (company-sponsored health, disability, life insurance)
- 401(k)
- Paid parental leave
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Director of Nonclinical Safety
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Cincinnati, Ohio, United States Orange Grove Bio Full timeAbout Orange Grove BioOrange Grove Bio is a leading integrated biopharmaceutical company dedicated to investing in groundbreaking technologies and developing therapies to profoundly improve patient lives. Our mission is to harness the full potential of cutting-edge research, driving innovation that addresses critical unmet medical needs across diverse...
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Director of Nonclinical Safety
2 weeks ago
Cincinnati, Ohio, United States Orange Grove Bio Full timeAbout Orange Grove BioOrange Grove Bio is a pioneering biopharmaceutical company dedicated to harnessing cutting-edge research to develop life-changing treatments. Our mission is to bridge regional gaps in venture capital funding and drive innovation that addresses critical unmet medical needs across diverse therapeutic areas.Opportunity:We are seeking an...
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