Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities. In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery.
EyeD Pharma and UniD Manufacturing lay the foundation stone of their future headquarters. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration. Our technological platform will be in the Science Park of Liège and will be up and running from 2022.
To support its development, EyeD Pharma is hiring a Nonclinical Development Specialist.
- Plan nonclinical development activities related to assigned project.
- Plan, perform, and lead nonclinical development studies to support drug and/or medical device development such as animal feasibility/pilot/pivotal studies, PK/PD studies, safety studies, and biocompatibility studies.
- Ensure efficient monitoring and follow-up of nonclinical activities subcontracted to third parties such as CRO.
- Write and review appropriate documentation including synopsis, protocols, reports, and Design History File deliverables including Nonclinical Development Plan.
- Lead and document dose determination activities for new drug products in development.
- Contribute to the preparation of nonclinical development sections of regulatory documents such as briefing documents for Scientific and Technical Advice meeting, IB, IMPD, Module 4 of AMM, and Biological Risk Assessment.
- Develop and maintain literature, regulations, and standards database knowledge for preclinical/nonclinical research.
- Provide scientific leadership for nonclinical development topics.
- Collaborate with team members (Pharmaceutical Development, QC, QA, Manufacturing, RA, and Clinical) to meet timelines for product development.
- Contribute to the establishment of effective project schedules and milestones.
- Contribute to Quality Risk Management activities as appropriate.
- Proactively identify development risk and work with the team to develop mitigation plans.
- University degree, preferably in biology, biochemistry, biomedical, pharmaceutical, or veterinary sciences.
- Minimum of 8 years of experience in R&D department of the pharmaceutical or medical device industry with a minimum of 5 years in nonclinical department.
- Good knowledge of nonclinical requirements for drug product, medical device, and/or combined product development.
- Good knowledge of OECD GLP guidelines.
- Experience in biological evaluation of medical device (ISO10993 series).
- European certificate in animal experimentation (FELASA) is an asset.
- Fluent in English and French.
- Strategic thinking, strong problem-solving and analytical skills.
- Strong written and verbal communication skills.
- Willingness to work in a multidisciplinary environment.
- Team player, Integrity, Benevolence
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company.
- Full time.
- Based in Liège
Please send your CV and cover letter in English to : email@example.com