At PostEra we embrace a low-hierarchy structure to foster efficient operations: · We believe time spent navigating complex hierarchies in organizations is better invested in the pursuit of groundbreaking technology and scientific discoveries. · Our organizational structure is intentionally minimalist, and we encourage mentoring, collaboration, and participation in conferences and continuing education, to support our team members' growth. · We promote a culture where individual achievement is celebrated through proportional compensation and internal recognition, including meaningful promotions. · Ultimately, our collective focus is delivering cures to patients which we believe needs a huge amount of cross-disciplinary collaboration, so we've fitted our organizational structure to serve that end.
What you would do
- Develop and execute preclinical studies (GLP and non-GLP) for inclusion in IND applications
- Select and manage contract research organizations (CROs) to support IND-enabling studies
- Build and oversee a network of consultants and CROs and CDMOs for CMC, toxicology, regulatory, formulation, and DMPK
- Collect, analyze, and interpret data generated from preclinical studies, providing insights and recommendations based on findings.
- Preparation of preclinical documentation to support regulatory submissions
- Proactively identifying potential risks associated with preclinical development activities and formulating appropriate risk-mitigating strategies to ensure project success
Experience and skills you should have
- 10+ years of experience leading pre-clinical development of small molecule programs in areas such as CMC, toxicology, regulatory, formulation, and DMPK
- Strong knowledge of pre-clinical drug development and FDA requirements
- Experience managing CRO partners
Bonus Experience and Skills
- Experience in reproductive medicine and women’s health
Visit us at postera.ai