Associate Preclinical Development Manager

Start Date: Immediate
The position is in Modi'in

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.

RESPONSIBILITIES:

  • 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).

QUALIFICATIONS:

  • 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