Enterome is searching for a Preclinical Director to design and conduct appropriate preclinical studies to support the development of microbiome-related clinical candidates. The role will have a strong focus on development of peptides and small molecule compounds derived from the human microbiome.
- Under the guidance of the CDO and in collaboration with Scientific and Medical stakeholders, drive the design of IND/CTA enabling pharmacology and required toxicology studies to support the development of a clinical candidate
- Select appropriate providers, partners, and CROs and manage conduct of outsourced experimental studies
- Prepare/review study protocols and reports, carry out data analyses and interpretation, and report findings to the project team(s)
- Contribute to preclinical sections in INDs/CTAs/BLAs etc.
- Provide study schedules and budgets to the project team and manage study against these timelines and budget objectives
- Present preclinical data to external partners
- Ensure compliance of all activities and protocols/reports with the Company quality system and regulatory guidelines
- Redaction of SOPs related to preclinical part
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
- Ph.D. in Biomedical Sciences; Master’s degree with strong experience may be considered.
- At least 5 year experience conducting or managing pre-clinical studies under GXP quality systems (IHC, immunogenicity studies, animal immunization, ELISpot, binding studies, tumor rejection, long term or tolerance tox studies/repro tox studies)
- Strong exposure to drug development in a biotech, pharma or CRO setting is a must-have
- Prior experience in Immuno-Oncology is required
- Ability to work independently and take responsibility for the progression of managed studies
- Demonstrated ability to analyze and resolve problems.
- Must possess excellent oral and written communication skills
- Experience working with animal and cellular models of disease and human tissue samples