SUMMARY OF JOB DESCRIPTION & RESPONSIBILITIES:
The candidate will be responsible for management of preclinical research (toxicology, PK, and pharmacology studies) and will contribute to relevant regulatory submissions in support of BioLineRx’s development pipeline.
- Manage all aspects of contracted preclinical pharmacology, safety (toxicology) and PK/PD studies at CRO vendors including study design, protocol development and review, active oversight/participation in conduct of studies (including on-site monitoring), management of reports, and review and oversight of bioanalytical/biomarker method development by CRO.
- Identify appropriate preclinical animal models to support pipeline products with CRO.
- Ensure that all preclinical activities related to the project are performed at high quality and within designated timelines.
- Serve as a core team member in cross-functional meetings and collaborate with multi-functional teams.
- Support writing, review, and QC of regulatory documents for submission to US and EU regulatory authorities.
- Design and set up in-house in vitro bioassays (including cell-based).
- Education: PhD in Biology/Life Sciences or Veterinary medicine - required
- Relevant industry experience - required
- Knowledge and experience in preclinical pharmacology, safety (toxicology) and PK/PD and relevant regulatory requirements – required
- Strong background in cell culture and in vitro bioassay settings - advantage
- Ability to review, understand and evaluate relevant scientific literature and professional data
- Experience with scientific writing and review: protocols, reports, SOP’s etc.
- Critical data analysis, problem solving and persuasive communication skills
- Self-motivated with ability to work independently with limited supervision
- Excellent team player with effective communication skills and ability to collaborate with multi-functional teams.
- Ability to work under pressure and heavy workload and willing to travel in Israel and abroad
- Fluent Hebrew and English, with good scientific English writing skills
Please email CV to hr@BioLineRx.com