26 days ago
This position is for a Scientist/Senior Scientist within the Toxicology Department of an innovative and growing clinical stage biotech focussed in immunology and fibrosis. The company pride themselves on their closenit, supportive and family atmosphere. The role will work within cross-functional teams and external bodies such as global regulatory bodies to support the product discovery and development. As the team is small and dynamic, you will learn key areas within Toxicology and Safety Pharmacology at a fast pace with lots of gaining responsibility as you grow with the role, fully supported and mentored with experienced team members. You will be involved with influencing the nonclincial safety strategy and be responsible for ensuring that molecules are optimized for safety before molecules are transitioned into clinical development. The person is also responsible for writing the safety pharmacology and toxicology sections of regulatory documents (IND/CTA/IB/NDA/MAA). This is a unique opportunity to make a big impact on a growing organization.
- Design, plan and conduct experiments closely with CROs for safety pharmacology and toxicology or investigative studies of drug candidates across the company pipline
- Analyze and interpret the in vitro and in vivo study data, provide the project team on risk assessment and issue management, including support of clinical study protocol development for human safety and efficacy trials.
- Manage CRO relationships including study protocols and reports, ensuring critical studies are to the required quality standard for regulatory submission
- Write/review nonclinical sections to support regulatory (IND/CTA/IB/NDA/MAA) filings and liase with regulatory bodies for any queries
SKILLS & REQUIREMENTS:
- Ph.D. or other equivalent field (such as DVM) with 1-3 years of relevant industry experience as a toxicologist in a pharma/biotech or as a study director/monitor
- Project Toxicology experience preferred
- DABT certified preferred
- Demonstrated success managing interactions with external CROs, consultants and other contract organizations is preferred
- Working knowledge of DMPK preferred
- Excellent organizational, interpersonal and verbal/written communication skills and ability to perform as an effective, flexible and self-assured team player.
- Ability to thrive in a fast-paced, dynamic and entrepreneurial environment.
If you would like to apply or be considered for similar roles please submit your resume and we will get back to you as soon as we can. If your skillset doesn't match this role or you know somebody who may be worth referring for this postion, drop over your resume/drop me a message or feel free to forward this on to a colleague.