Requirements: English
Company: Medincell
Region: Montpellier , Occitanie
Preclinical Safety Leader (M/F)- CDIMedincell is a commercial-stage pharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Products of our portfolio are based on our BEPO technology and aim to ensure patient compliance, improve the effectiveness and accessibility of treatments, and reduce their environmental footprint. We collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options.
We are looking for a Preclinical Safety Leader which is main mission is to drive our toxicology studies efforts, ensuring the safety and regulatory compliance of our drug development programs. He/She will also drive the application of toxicology scientific expertise across theorganization and manage the toxicology team.
Missions
Scientific Leadership
:Provide Toxicology scientific expertise to preclinical project teams, contributing to decisions on dose selection, study design, and development strategiesDevelop and implement risk assessment strategiesStay current with advancements in toxicology and regulatory sciencePreclinical Study Design
: Lead the design and execution of preclinical toxicology studies, including in vitro and in vivo experiments, to support drug discovery and developmentData Analysis & Interpretation
: Analyze and interpret safety data from preclinical studies, ensuring clear scientific communication and integration into overall project strategiesRegulatory Support
: Prepare and support regulatory documents such as Briefing Document and IND documents, ensuring compliance for the development and registration of new drugsCollaboration
: Work closely with cross-functional teams, including pharmacokinetic, formulation, clinical and regulatory teams, to ensure comprehensive preclinical evaluation of drug candidatesMentorship
: Coach, manage and mentor the toxicology team, providing strategic direction and oversight
Requirements
Minimum of 10 years of experience in Toxicology within the pharmaceutical industry, long-acting injectables would be a plusMaster or Ph.D. in Toxicology, Pharmacology, or a related fieldStrong knowledge of regulatory requirements and guidelines (e.g., GLP, ICH)Expertise in non-clinical strategies to support the product development and regulatory submissionsProven leadership and team management skillsStrong analytical and problem-solving abilitiesFrench and Fluent in English, spoken and written ability to attend complex meetings and write clear documentationExcellent communication and interpersonal skillsAbility to work effectively in a fast-paced, dynamic environment
Competitive package composed of:Competitive Base SalaryBonus and Profit SharingFree share granted by the company (Medincell employees are also shareholders) Lunch vouchers (9 per day, 60% paid by the company)Relocation assistance available Sport and yoga sessions onsite available 4 times a weekMonthly socializing eventsVery flexible working hours and home office policy
Medincell is an equal opportunity employer welcoming applications from all individuals, including those with disabilities.