- Serve as nonclinical safety subject matter expert on project teams from discovery into early development.
- Design and execute nonclinical safety strategies and provide development plans for biologics in oncology and immunology.
- Analyze, interpret and summarize GLP and non-GLP safety data to internal teams.
- Provide risk assessment and implement de-risking strategies in discovery teams to support candidate selection.
- Author regulatory documents including Investigator Brochures and IND/CTAs, and interact with regulatory agencies (US and ex-US) as needed.
- You will be responsible for oversight and interaction with consultants and CROs assigned to support nonclinical safety.
- DVM or PhD in toxicology, pharmacology, or related discipline.
- >5 years of experience in nonclinical safety supporting early development of biologics in a biotech or pharmaceutical organization.
- Prior nonclinical safety experience with biologics in oncology is required.
- Experience with regulatory submissions in early development is required.
- Experience working on T-cell based therapeutics, particularly multi-specific T-cell engagers is preferred.
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Nonclinical Safety Leader - Philadelphia, United States - Christine Mathews Consulting, a OneDigital Company
Description
Company Background:
Stealth, VC-backed, discovery-stage biotech company with significant funding focused on discovery and development of breakthrough biologics in Oncology and Immunology. This small but experienced team is currently expanding headcount to support the next phase of growth through IND submissions and clinical development.
Position Summary:
As Nonclinical Safety Lead, you will work in our early development teams with a responsibility for designing and executing on the nonclinical safety strategy for novel biologics, connecting the project from discovery into IND-enabling and FIH studies. As the nonclinical safety subject matter expert, you will be responsible for the nonclinical toxicology studies in support of IND submission.
Essential Functions:
Experience:
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity/expression, national origin, disability, medical condition, age, marital status, status as a protected veteran, or any other legally protected characteristic.
