The Company
Mana.bio is an early stage venture backed AI based drug delivery startup, focusing on the delivery of oligonucleotide therapies including mRNA-based therapeutics, vaccines and gene therapy. The technology is powered by an integration of machine learning and nanotechnology in order to develop drug delivery systems.
The Role
We are seeking a highly skilled and motivated individual to lead our preclinical development efforts with proven experience in submitting INDs. The Head of Preclinical Development will be responsible for planning and executing the preclinical programs through IND submission.
The role includes collaboration with R&D to identify and launch innovative early research programs, and developing evidence to support their clinical application. As part of this role, you will establish the strategy of the preclinical studies at Mana.bio.
The role requires a broad range of scientific and medical expertise relevant to translational research, early clinical development, as well as the ability to analyze and interpret data in scientific and disease specific contexts.
Responsibilities
Plan and execute preclinical studies towards IND submission
Ensure that preclinical studies are conducted in compliance with regulatory guidelines and Good Laboratory Practices (GLP)
Identify early research programs and launch their preclinical studies
Lead a team of scientists to execute the preclinical studies
Oversee the analysis, interpretation, and reporting of preclinical study data
Manage the preclinical study budget and resources
Prepare preclinical study reports and regulatory documents
Collaborate with the R&D teams to facilitate the translation of drug candidates from preclinical to clinical development
Present preclinical study results to internal and external stakeholders
Requirements
PhD or MD/PhD in a relevant scientific discipline (e.g. pharmacology, toxicology, biochemistry, biomedical, or a related field)
Proven successful experience in leading preclinical programs from candidates to IND submission
5+ years of experience in preclinical drug development
Proven ability to lead internal and external stakeholders
Strong knowledge of GLP and regulatory guidelines for preclinical studies
Excellent written and verbal communication skills, with the ability to effectively communicate preclinical study results to both technical and non-technical stakeholders
Strong project management skills, with the ability to manage timelines, budgets, and resources