Outsourcing Manager (DMPK)

Ipsen Pharma

Les Ulis, France

Summary/purpose of the position

The Outsourcing Manager will handle and supervise all DMPK outsourcing activities, including in vitro ADME and in vivo PK studies. The selected candidate will ensure high quality and timely delivery of data and reports to support programs from discovery through post-marketing commitments.

This role requires close collaboration with DMPK project representatives, contract management, finance, and procurement. Additionally, the individual must build and maintain strong working relationships with Contract Research Organizations (CROs) worldwide.

Main responsibilities/job expectations

Outsourcing Management

Identify, evaluate, and select appropriate CROs for in vitro ADME and in vivo PK studies;
Design study protocols in collaboration with DMPK project representatives;
Follow up on contracts and ensure PO approval and modifications as needed;
Ensure timely initiation of the study (shipment of materials, etc.);
Supervise critical phases of the study and ensure timelines are met within project needs;
Serve as point of contact between internal teams and external CROs.

Regulatory Compliance

Ensure the appropriate regulatory compliance is met for the study given the stage of the project;
Maintain records of study conduct, data and communications for future audits;
Ensure in vivo studies are designed to comply with Ipsen’s animal welfare policy.

Data Review

Review study data to ensure appropriate adaptation of the study protocol;
QC data tables and reports;
Review content of draft reports to ensure compliance with study goals.

Data Reporting

Upload discovery data and into database;
Laise with DMPK representative to finalize reports and upload into document management system.

Experience/Qualifications

Educational level in DMPK or related field with 2-5 years of experience in CRO or pharmaceutical industry;
Experience with CRO management is highly desired;
Operational level of English is required;
Experience with bioanalysis and immunoanalysis a plus.