Scientist Clinical Biomarkers - Les Ulis, France - IPSEN

IPSEN
IPSEN
Entreprise vérifiée
Les Ulis, France

il y a 2 semaines

Sophie Dupont

Posté par:

Sophie Dupont

beBee Recruiter
Description

Title:

Scientist Clinical Biomarkers H/F


Company:

Ipsen Innovation (SAS)


The clinical Biomarkers scientist will be responsible for successfully driving biomarkers activities, for multiple programs covering all three therapeutic areas (Oncology, Neuroscience, Rare Diseases), where needed.

He/She will contribute to define biomarker plans for each relevant program, from identification up to clinical validation and implementation. He/She will also be responsible for monitoring biomarkers in clinical trials as well as implement and support cross-functional process optimization in conjunction with other biomarker-related operations


Primary responsibilities:


  • Contributes to the development of biomarker plans for target engagement, pharmacodynamics, mechanism of action, and patient selection that are suitable for informed decisionmaking
  • Selects the most relevant technical strategy to fulfill biomarker objectives (FACS, tissue imaging, genomics, proteomics)
  • Implements biomarker plans for clinical trials into clinical study documentation (Protocols, SoW, lab manual)
  • Identifies, selects and validates CROs for biomarker validation and analysis to ensure compliance and highquality data
  • Actively participates in meetings and effectively interfaces with technical/scientific experts in all functions to deliver on biomarker goals
  • Works closely with clinical operation teams and CROs, to monitor ongoing biomarker activities, ensure appropriate collection and analysis of biomarker samples, coordinate biomarker data analysis and interpretation of the results, and collaborate to define biomarker components of statistical analysis plans
  • Drive compliant management of biobanking samples in long term storage CRO and in appropriate tools (LIMS).
  • Manages outsourcing process according to Ipsen SOPs (budget, contracts )
  • Communicates effectively and impactfully across the organization within REED and with Clinical Development, Project Management, Regulatory, R&D and BD.
  • Ensures compliance with appropriate SOP's
  • Maintains knowledge of national and international guidelines including industry standards for Good Laboratory/Clinical Practice

Education / Certifications:

  • Minimum requirements/Education (minimum/desirable):
  • PhD + Post doc in life science, preferably in oncology or immunooncology; ability to travel up to 5%
  • An equivalent combination of relevant education and applicable job experience may be considered.

Experience:

  • 5+ years experience in drug development in the pharmaceutical industry or in biotech, including 2+ years experience in early phase clinical biomarker

Languages:

  • English: Business level, oral and written
  • French: Business level, oral and written

Key Technical Competencies Required

  • Eager and interested in learning and growing
  • Deep understanding of the role of translational science and clinical biomarkers in drug development
  • Comfortable working in a fastpaced environment
  • Comfortable working in or leading a matrix team
  • Ability to recognize, articulate, and accept calculated risks to make informed decisions
  • Working knowledge of all functional areas of drug development, including pharmacology, toxicology, clinical development, clinical operation, quality assurance, diagnostic development
  • Demonstrated scientific acumen and mechanistic understanding of disease biology
  • Good analytical and problemsolving skills
  • Excellent scientific written, interpersonal communication
  • Strong familiarity with good clinical/laboratory practices
  • Good experience working with CROs.
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