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 Clinical Project Leader.
The Clinical Project Leader participates in strategic discussions regarding the design of clinical studies as well as supportive non-clinical studies on human material by working collaboratively with CMO and Core Teams members (including non-clinical, RA and CMC teams). He/She leads and manages clinical study activities and supportive non-clinical studies on human material to meet targets according to projected timelines, identifies risks for the successful conduct of the studies and implement solutions.
- Participates in strategic discussions regarding the design of clinical studies as well as supportive non-clinical studies on human material by working collaboratively with CMO and Core Teams members (including non-clinical, RA and CMC teams).
- Identifies risks for the successful conduct of the studies and implement solutions.
- Leads and manages clinical study activities and supportive non-clinical studies on human material to meet targets according to projected timelines including but not limited to :
- Lead preparation of all study-related documents (eg ICF, IB, Protocol, CRF, study reports etc.);
- Write appropriate documentation including study synopsis, study protocols and study reports for non-clinical studies and analyse, interpret, and discuss study results;
- Lead study start-up process, including, vendor selection, site selection and finalization of site and vendor Clinical Trial Agreements, set-up of TMF;
- Manage contacts with Ethics Committees and CTA submissions;
- Ensure effective study plans are in place;
- Chair clinical study group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed;
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team;
- Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner;
- Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements;
- Ensure TMF completeness in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures;
- Follow-up and coordinate the nonclinical/clinical studies with the Contract Research Organisations (CRO).
- Bachelor’s degree in Life Sciences, Nursing Licensure or Pharmacy
- Minimum of 4 years of project leadership in clinical and/or non-clinical fields (both fiels preferred); with responsibility in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods
- Therapeutic experience in ophthalmology and/or medical device (preferred)
- Experience in non-clinical studies and early phase trials (Phase I-II) (preferred)
- Ability to work within a team
- Ability to be productive and successful in an intense work environment, result oriented
- Excellent organization and project management skills
- Good negotiation and communication skills
- Read, write and speak fluent English
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company
- Full time
Please send your CV and cover letter in English to : firstname.lastname@example.org