Non-Clinical Project Leader
- Ness Ziona
about this position
A young and dynamic Israel-based microbiome company is looking for a highly-motivated, experienced person to lead the pre-clinical in vivo studies across all projects. The successful candidate will have a strong scientific background and previous experience with pre-clinical drug development studies. The candidate will have excellent interpersonal skills and managerial capabilities to lead the project within a matrix-like organizational structure while managing external CROs. The successful candidate will report to Discovery Senior Director.
The role includes:
Manage all BiomX’s animal studies. This includes oversee several models across the pipeline indications.
Oversee multiple aspects of in vivo studies: Pharmacology studies (MoA and efficacy), Safety and toxicity, Pharmacokinetics and pharmacodynamics studies. Both non GLP and GLP.
Managing of all activities related to the studies, from the details of the science behind the need through the strategic planning and understanding the regulatory path and requirements.
Leading a small team of scientists
Many activities are handled outside of BiomX. Project Leader will establish and manage outsourced activities with CROs and consultants.
Project Leader will lead and coordinate related activities with different units within the company.
Responsible for studies reports for IND submissions.
Development of a biological product requires constant handling of dynamic and unforeseen challenges. Head of in vivo will constantly evaluate gaps in the program and provide solutions within the company and via external resources
- PhD in Life Sciences, Biotechnology or equivalent
- 4-5 years of relevant industry experience in a similar position
- Experience in drug development pharmacology studies (MoA and efficacy), safety and toxicity, pharmacokinetics, and pharmacodynamics studies. Both non GLP and GLP.
- Previous experience in pre-clinical activities for regulatory submissions (FDA; EMA)
- Ability to assess and prioritize multiple tasks and demands within an interdisciplinary environment
- Background in biological drugs development (large molecules)
- Microbiology background- advantage
- Attention to details with excellent organization skills and accurate record keeping
- Collaborative and effective communication skills are essential
- Qualified candidate should be motivated, collaborative and creative with the ability to work in dynamic environment and contribute to execution of in vivo animal studies.