Outsourcing manager DMPK FM
Outsourcing manager DMPK FM
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Job Description
Title:
Outsourcing manager (DMPK) F/MCompany:
Ipsen Innovation (SAS)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 postmarketing 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 Ipsens 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 25 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
#LIMC1
#LIHybrid
Dans le cadre de ses recrutements IPSEN sengage au respect de lgalit de traitement des candidats indpendamment du sexe de lge de lorientation sexuelle de lorigine ethnique de la couleur de la peau de la nationalit du handicap ou de lappartenance un syndicat.Required Experience:
Manager
Employment Type
Full-Time
