Junior Discovery Pharmacokinetics Outsourcing Partner

Sanofi

Frankfurt am Main, Germany

About the job

As Junior Discovery Pharmacokinetics Outsourcing Partner VIE within our Discovery and Translational Sciences you will play a key role in supporting the externalization and execution of preclinical pharmacokinetic (PK) and toxicokinetic (TK) studies across drug research and early development.

Main responsibilities:

Study Management: Serve as the study coordinator for the outsourcing and operationalization of preclinical PK and TK activities, ensuring scientific integrity, adherence to timelines, quality deliverables, and budget compliance.
Central Point of Contact: Act as liaison for all discovery PK/TK-related activities, — both internal and external — providing the team with high-quality data to support informed decision-making.
Study Oversight: Supervise all phases of pharmacokinetic studies, including in-life operations, bioanalysis, and PK/TK evaluation, conducted both in-house and at external Contract Research Organizations (CROs). Provide scientific and technical guidance as needed.
Cross-functional Collaboration: Work closely with internal drug formulation, in-life, and bioanalysis teams to ensure rigorous study planning and seamless execution.
Digital & Data Management: Configure study designs in the cloud-based platform Benchling and manage data imports into internal databases. Collaborate with digital teams to ensure the effective use and continued development of software solutions.
Vendor Management: Build and maintain strong relationships with CROs, ensuring all external activities are conducted in alignment with quality standards, project timelines, and contractual requirements.

About you

Experience:

Prior experience in monitoring and managing external vendor activities.
Hands-on experience with complex data sets and proficiency with Certara's Phoenix and D360 software solutions would be an asset.

Soft and technical skills:

Solid understanding of non-clinical in vivo PK study design, LC/MS- and LBA-based bioanalysis, and PK/TK evaluation.
Working knowledge of GxP regulations and the ability to identify and troubleshoot issues arising from external vendor study activities.
Strong communication skills with the ability to collaborate effectively across multiple teams and stakeholder groups, with a focus on quality and timeliness.
Demonstrated ability to manage vendor relationships and ensure study requirements are met efficiently.

Education:

Degree in Pharmaceutical Sciences, Biology, Chemistry, or a related discipline, with experience in the pharmaceutical industry — preferably in drug research and development.