Description
What you would do
Develop and execute preclinical studies (GLP and non-GLP) for inclusion in IND applicationsSelect and manage contract research organizations (CROs) to support IND-enabling studiesBuild and oversee a network of consultants and CROs and CDMOs for CMC, toxicology, regulatory, formulation, and DMPKCollect, analyze, and interpret data generated from preclinical studies, providing insights and recommendations based on findings.Preparation of preclinical documentation to support regulatory submissionsProactively 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 DMPKStrong knowledge of pre-clinical drug development and FDA requirementsExperience managing CRO partners
Bonus Experience and Skills
Experience in reproductive medicine and women’s health
Salary: 180k-220k
Equity: 0.1% - 0.2%
Visa Sponsorship: Not at this time
Hiring Manager: Alpha Lee
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