PK Scientist

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 seeking a highly skilled and experienced PK Scientist to join our dynamic team. The successful candidate will play a crucial role in designing and managing preclinical pharmacokinetic studies to support our drug development programs.

Missions

Pharmacokinetic studies and Qualification/Validation of bioanalytical methods:

• Write and review the study synopsis (study type, animal species, dose, duration, frequency of administration, parameters to be evaluated, etc.)
• Coordinate with Contract Research Organizations (CROs) for study execution
• Manage study logistics and ensure compliance with protocols and regulations
• Analysis and interpretation of in-vivo data
• Analysis and interpretation of PK data: carry out PK analysis (non-compartmental)
• Write up the PK phase reports
• Ensure on-time delivery of key data and study reports
• Review and archive study documentation
• Share results by preparing presentations to business/partners and scientific audiences (project teams, other functional teams), through both oral presentations (internal and external meetings)

Contract Research Organizations (CROs) Management:

• Regularly monitor and review the technical capacities of various CROs
• Negotiate proposals/quotes with the sales teams of CROs
• Manage confidentiality agreements (CDAs) and service contracts
• Ensure the proper maintenance of CROs’ database

Regulatory support:

• Assist in the collecting of non-clinical PK/PD literature data on drug substances
• Support the establishment of non-clinical PK strategy
• Review any TK/PK materials for regulatory submissions

Profile

• Master's degree (or equivalent) in a relevant scientific discipline (e.g., pharmacology, toxicology, biology).
• Extensive experience in preclinical study management, preferably within a CRO.
• Experience in the in vivo Pharmacokinetic analysis of small molecules
• Strong knowledge with PK software as Phoenix
• Experience in in vivo PK studies by subcutaneous route in rodent and non rodent is highly desirable.
• Experience in the qualification/validation of bioanalytical methods is highly desirable.
• Strong project management and organizational skills.
• Experience coordinating with transversal teams.
• Proficiency in both French and English.