Outsourcing manager (DMPK) F/M

Title:

Outsourcing manager (DMPK) F/M

Company:

Ipsen Innovation (SAS)

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

Job Description:

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. 

Key Required Technical Competencies
Strong project management skills 
Ability to work in a team within a multidisciplinary environment 
Excellent communication and negotiation abilities

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Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.