We at Clexio view our team as our key component to our success.
We work and act by the values we have defined together, representing the culture we believe in.
We are promoting a work environment that is based on mutual respect, transparency , collaboration, high
energy and strong drive to make an impact , openness to new ideas as well as committing and owning our
deliverables so that we can truly make a difference for our patients.
We have an exciting roadmap that we are committed to seeing through with the most talented and
creative team of professionals.
looking to recruit talent for the following positions
- Design ,lead and oversees execution of phase 1 studies
- Lead the development of the phase 1 clinical study protocol and manage the execution of study related documents including regulatory submission package
- Oversee and monitor CROs for Clexio Phase 1 studies
- At least BSc (PhD advantage) in pharmaceutical/life sciences, MD or any other relevant education (preferable: Pharmacy, Clinical Pharmacology, Medical Sciences)
- 5 years of experience in drug development / clinical trials
- Knowledge in Clinical Pharmacology/Pharmacokinetics- Advantage
- Ability to work in a multi-disciplinary environment
- Strong communication skills (Hebrew, English) and collaboration
- Plan and conduct scientific experiments to create formulation prototypes
- Design & execute various laboratory studies on assigned dosage forms/new products based on QbD principles
- Prepare, review and/or approve written documents to support relevant studies, research projects, regulatory submissions etc.
- Coordination of scientific studies with additional company disciplines and/or with external CROs
- A relevant PhD degree in life Sciences (pharmaceutical sciences or other relevant discipline) with hands-on laboratory experience
- At least 3 years of experience in the pharmaceutical industry (or equivalence academic experience)
- Experience with semi-solid dosage form formulation development and evaluation. Viscosity, Franz cells skin permeability, pH, and Osmolarity techniques – advantage
- Fluent in English with good writing skills
- Lead role in building regulation-compliant pharmacovigilance processes and systems
- Key role in preparation of safety documents for regulatory authorities for drugs in development
- Collaboration with Safety Physician on clinical trial safety data analysis and safety surveillance for drugs in development
- Pharmacovigilance aspects of clinical trials including coordination of pharmacovigilance and safety activities with partners
- Degree in Clinical Pharmacy, Pharmacology, Biological or Medical Sciences, or Nursing
- At least 3 years previous experience in pharmacovigilance of drugs in development
- Strong knowledge of pharmacovigilance processes and regulation
- Very high level English