Preclinical Safety Leader (M/F)

Preclinical Safety Leader (M/F)- CDI

Medincell 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 the

organization 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 strategies
• Develop and implement risk assessment strategies
• Stay current with advancements in toxicology and regulatory science
• Preclinical Study Design: Lead the design and execution of preclinical toxicology studies, including in vitro and in vivo experiments, to support drug discovery and development
• Data Analysis & Interpretation: Analyze and interpret safety data from preclinical studies, ensuring clear scientific communication and integration into overall project strategies
• Regulatory Support: Prepare and support regulatory documents such as Briefing Document and IND documents, ensuring compliance for the development and registration of new drugs
• Collaboration: Work closely with cross-functional teams, including pharmacokinetic, formulation, clinical and regulatory teams, to ensure comprehensive preclinical evaluation of drug candidates
• Mentorship: 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 plus
• Master or Ph.D. in Toxicology, Pharmacology, or a related field
• Strong knowledge of regulatory requirements and guidelines (e.g., GLP, ICH)
• Expertise in non-clinical strategies to support the product development and regulatory submissions
• Proven leadership and team management skills
• Strong analytical and problem-solving abilities
• French and Fluent in English, spoken and written ability to attend complex meetings and write clear documentation
• Excellent communication and interpersonal skills
• Ability to work effectively in a fast-paced, dynamic environment

Competitive package composed of:

💼 Competitive Base Salary

💰 Bonus and Profit Sharing

📈 Free 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 week

🎉 Monthly socializing events

🕒 Very flexible working hours and home office policy

Medincell is an equal opportunity employer welcoming applications from all individuals, including those with disabilities.