Salary: Up to €50,000 + Benefits
CPL Life Sciences are supporting a growing, Dublin based biopharmaceutical company to add a Senior Clinical Scientist to their team. This company is focused on the development and commercialisation of innovative rare and orphan disease products to patient populations around the world.
Reporting directly to the VP of Product Development, the Senior Clinical Scientist will play a key role in the development of drug products from a clinical and scientific perspective. You will work collaboratively with cross-functional teams to aid trial design, protocol development, start up and close out activities, data analysis and support regulatory submissions.
- Input into the development of specific study concept sheets and protocols.
- Participate in protocol review discussions concerning scientific and procedural aspects of
- Contribute to the design and development of CRFs and Data Analysis Plans
- Assist with the preparation and review of regulatory documents, IND annual reports, IND
safety reports, Investigator Brochures and NDAs/MAAs
- Assist in the preparation of regulatory documents, IND annual reports, IND safety
reports, Investigator Brochures and NDAs/MAAs
- Minimum 3 years' of relevant scientific and/or drug development experience within a
pharma, biotech, academic trial environment
- Protocol development/trial design
- Demonstrable experience of working cross-functionally with global teams
- Good knowledge of FDA, EMA and ICH regulations and guidelines
- PhD or BSc educated
This role comes with a competitive basic salary and benefits that includes flexible home-working. You will play a pivotal role within a small but growing organisation, working on orphan drug products. If this role is of interest, please send your CV to George.Danchie@cpl.com or call 0118 959 4990 to discuss.