Translational PKPD Lead

Translational Pharmacokinetics Lead

Overview

An exciting opportunity for an experienced PK modeler to join my clients expanding team. I am currently working with a commercial-stage global pharmaceutical company, with assets across multiple therapeutic areas. The team are based onsite in the South of France are looking for an experienced Translational PK Scientist to support the non-clinical and clinical development of their lead candidates. This is a really exciting opportunity to join an expanding and developed team with an excellent work culture for a globally recognised organisational in the pharmaceutical space.

Responsibilities

Pharmacokinetic Analysis & Modeling

• Conduct comprehensive PK/PD analysis for non-clinical and clinical studies
• Develop and implement pharmacokinetic models to optimize product dosing and efficacy using standard software (WinNonlin, NONMEM)
• Manage and coordinate modeling consultants to achieve project objectives
• Collaborate with dedicated teams on in vitro-in vivo correlation (IVIVC) projects

Clinical Development Support

• Design and oversee Phase I clinical studies
• Provide strategic support for clinical development plans
• Review critical study documentation including protocols, Statistical Analysis Plans (SAP), and Clinical Study Reports (CSR)
• Monitor development and validation of bioanalytical methods

Regulatory & Documentation

• Collaborate with regulatory affairs and clinical teams on regulatory documentation (IMPD, IND, IB)
• Prepare and contribute to PK and modeling reports
• Present findings to project teams, senior management, and partners
• Participate in Target Product Profile (TPP) definition

Scientific Leadership

• Stay current with scientific advancements in the field
• Apply cutting-edge knowledge to ongoing projects
• Contribute to scientific strategy and decision-making

Required Experience & Skills

• PhD or Master's degree in Pharmacokinetics, Pharmacology, or related field
• 5-10 years' experience in PK/PD, non-clinical and clinical PK, and PK modelling
• Familiarity with regulatory requirements and documentation processes
• Proficiency with PK software including WinNonlin and NONMEM
• Demonstrated experience in translational PK modeling
• Strong knowledge of statistics and statistical software (preferably R)
• Experience managing consultants and leading projects
• Fluency in English (French proficiency highly desirable)

My client is looking for the right person to join their team and is willing to pay competitively according to experience along with generous package and benefits options. This is an onsite role