Translational Pharmacokinetics 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 Translational PK Scientist to join our dynamic team to support the non-clinical and clinical development for our LAI candidates. The ideal candidate will have a strong background in pharmacokinetics/pharmacodynamics (PK/PD), non-clinical and clinical PK, PK modeling, and in vitro-in vivo correlation (IVIVC).

Key Responsibilities:

• PK/PD Analysis: Conduct and oversee PK/PD analysis for both non-clinical and clinical studies.
• PK Modeling: Develop and implement PK models to optimize dosing and efficacy of Medincell’s products using
• standard software such as WinNonlin and NONMEM.
• Consultant Management: Manage and coordinate with modeling consultants to ensure project goals are met.
• Presentation and Reporting: Present findings to project teams, top management, and partners. Prepare and
• contribute to PK and modeling reports.
• TPP Definition: Participate in the definition of Target Product Profiles (TPP).
• Regulatory Documentation: Collaborate with regulatory affairs and clinical teams to write and review the non-
• clinical and clinical parts of regulatory documents (IMPD, IND, IB).
• Clinical PK Responsibilities:
• # Phase I Study Design: Design and oversee Phase I clinical studies.
• # Clinical Strategy Support: Provide support for the clinical strategy, ensuring alignment with overall project goals.
• #Documentation Review: Review study documentation including protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSR).
• #Bioanalysis Method Development: Monitor the development and validation of bioanalytical methods.
• Scientific Watch: Stay updated with the latest scientific advancements in the field and apply this knowledge to ongoing projects.
• IVIVC Work: Collaborate with a dedicated team on IVIVC projects.

Required Skills and Qualifications:

• Experience: 5-10 years of relevant experience in PK/PD, non-clinical and clinical PK, and PK modeling.
• Software Proficiency: Proficient in using PK software such as WinNonlin and NONMEM.
• Translational PK Modeling: Experience in translational PK modeling.
• Statistics Knowledge: Ideally, good knowledge in statistics and the use of statistical software R.
• Communication: Excellent verbal and written communication skills for presenting data and writing reports.
• Team Collaboration: Ability to work collaboratively with cross-functional teams including regulatory affairs and
• clinical teams.
• Leadership: Experience in managing consultants and leading projects.
• Language Skills: Proficiency in English is required; proficiency in French is highly desirable.

Preferred Qualifications:

• Advanced Degree: PhD or Master in Pharmacokinetics, Pharmacology, or a related field.
• Regulatory Knowledge: Familiarity with regulatory requirements and documentation processes.
• Problem-Solving: Strong analytical and problem-solving skills.