Senior Preclinical Project Leader

Published on 31/01/2023

Responsibilities

Ensure the role of study Director according to GLP guidelines
Organize and conduct PCL studies with team, partners and CRO
Follow regulatory requirements (EMA/FDA) for all class of compound (ATMP, drugs and Medical Devices)
Improve GLP compliance of the PCL Dept in collaboration with the non-clinical QA officer
Write and approve study plans and study reports
Ensure integrity, quality & completeness of data
Ensure statistical analysis
Respect and implement quality system (SOP/LOG), if necessary
Implement new innovative techniques/ tools to support growing of PCL dept.
Train and support PCL team
Participate actively to weekly meetings

Profile

Completed PhD or Post-doc working /developing animal models
Past experience (minimum 4 years) as Preclinical project leader in Biotech/Pharma or within a CRO
Felasa C
Knowledge of regulatory requirements (guidelines) for Medical devices, ATMP and drugs
Past experience with NC package and IMPD completion is a plus
Excellent communication and interpersonal skills
Data-driven, team player and problem-solving skills
Fluent in French and English (verbal and written)
Driving license with own car

Offer

The contract is for a full-time and hybrid job.
You will work in a respectful, human-sized, and quality environment. You will be a key player in an enthusiastic, scientific and motivated team, where you can grow and directly contribute to the success of the preclinical dept.

Application

If you correspond and are interested to apply to this position, please send a cover letter and CV both in English to Sandra Pietri : sandra.pietri@artialis.com.

Senior Preclinical Project Leader

Responsibilities

Profile

Offer

Application

Location

Contact