Clinical Scientist

Firalis is a biotechnology company with a mission to improve disease outcomes, therapeutic decisions and generate savings in healthcare through biomarker discovery, development and regulatory qualification ultimately leading to biomarker-based diagnostics. With a strong expertise and a high-quality environment (ISO 9001, ISO 13845, ISO 17025 and NF S 96-900), Firalis manufactures RUO and IVD kits and provides a comprehensive range of biomarker services from research to clinical trials in key therapeutic areas. Located in Huningue, its head office includes more than 2000 m2 of R&D and production laboratories.

To strengthen the Regulatory Affairs and Clinical Operations team of our company, we are looking for a:
**CLINICAL SCIENTIST (W/M)**

**Job Overview**:
**Key Responsibilities**:
As a Clinical Scientist, your main missions will be to:

- Participate in regulatory submissions for approval of IVD devices
- Participate in the preparation of IVD device technical files and briefing books for regulatory approvals
- Collaborate with R&D, production and quality teams to generate all regulatory documents related to labeling, packaging and marketing
- Collaborate with R&D, production and quality teams to prepare IVD device instructions for use, analytical validation plan and reports
- Participate and provide recommendations on the development, design, validation and production of new IVDs
- Verify that the device development process complies with FDA and CLSI guidelines
- Collaborate with cross-functional teams to develop study protocols, CRFs, informed consent forms, SOPs, investigator brochures, monitoring plans and other study documents
- Participate in obtaining start-up and modification authorizations for clinical studies from competent authorities and ethics committees throughout the EU
- Be in charge of clinical site management and monitoring
- Control the veracity, quality and standardization of data
- Write clinical study reports.

**Your profile**
- PhD or equivalent degree in biology, biochemistry, biotechnology, or a related scientific field
- Prior experience in clinical research and clinical trial design
- Strong knowledge of regulatory requirements and GCP guidelines
- Detail-oriented with strong organizational skills
- Excellent analytical and problem-solving skills.
- Exceptional communication and presentation abilities.
- Fluent written and spoken English and French
- Experience in neurodegenerative or cardiovascular disease would be an asset
- Proficiency in data analysis software and statistical tools (e.g., SAS, R, or Python) is a plus.

If you meet the above requirements, we would love to hear from you. Please submit your resume and cover letter for consideration.

Type d'emploi : Temps plein, CDI

Salaire : à partir de 35 000,00€ par an

Avantages:

- Épargne salariale
- Horaires flexibles
- Prise en charge du transport quotidien

Programmation:

- Du lundi au vendredi
- Travail en journée

Types de primes et de gratifications:

- Primes

Formation:

- Bac +5 (Master / MBA) (Requis)

Expérience:

- recherche clinique: 1 an (Requis)

Lieu du poste : En présentiel