Company Description
Orange Grove Bio is an integrated biopharmaceutical company dedicated to investing in groundbreaking technologies and developing therapies to profoundly improve patient lives. Founded to bridge regional gaps in venture capital funding, our leadership team combines seasoned pharma executives and healthcare investment and operational experts who actively participate in guiding growth-stage companies to success.
Based in Cincinnati, we forge strategic alliances to accelerate the translation of scientific breakthroughs into life-changing treatments. Our mission is to harness the full potential of cutting-edge research, driving innovation that addresses critical unmet medical needs across diverse therapeutic areas.
Opportunity:
Outstanding opportunity for an exceptional Director of Nonclinical Safety (Toxicology) to join a rapidly growing team. This role 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, in collaboration with project teams, CROs and consultants. The person in this role will interface with various functional groups within the company and will report to our Vice President of Operations and Early Development
Job Description:
• 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.
• Collaborate with colleagues (e.g., CMC, Clinical, Regulatory, and/or Venture) 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
Key Responsibilities:
•This role 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, in collaboration with project teams, CROs and consultants
•The person in this role will interface with various functional groups within the company and will report to our Vice President of Operations and Early Development.
•Develop the strategy of 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.
•Collaborate with colleagues as needed 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
Required Qualifications:
•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
These Qualifications Will Help This Role Be Successful:
• 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 submissions 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
• DABT certification preferred but not required
• Ability to navigate, problem-solve, execute, and lead in a dynamic, fast-paced, and evolving environment
The salary range for this position is: $180,000 - $220,000. Orange Grove Bio considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a SHRM membership reimbursement, discretionary annual bonus, unlimited paid time off, a comprehensive benefits package (company-sponsored health, disability, life insurance), 401(k), and paid parental leave.
