close

Specialist Scientist in Clinical Pharmacology and Immunology

Other
Eysins
English

Specialist Scientist in Clinical Pharmacology and ImmunologyAre you interested in working in pharmaceutical manufacturing and in joining a well established and dynamic organization ? Type of contract : PermanentLocation: Canton of Vaud Your responsibilities:

  • Oversee, coordinate and guide activities performed at bioanalytical laboratories regarding PK/PD and immunogenicity method development, validation and sample analysis, before and during the execution of clinical studies
  • Collaborate with clinical operations and clinical CRO to ensure adequate PK/PD and immunogenicity sample collection, management, handling and shipment
  • Work with project management to align timelines and budget within the overall development plan
  • Responsible for Bioanalytics e2e procurement process, and for managing contracts with bioanalytical laboratories
  • Contribute to inspection readiness by filing bioanalytical documents in the eTMF and prepare for inspections
  • On bioanalytical and clinical pharmacology and immunology topics, contribute to regulatory submissions, briefing books and consultations with health authorities

 Your profile: Education: Advanced scientific degree (MsC, MD or equivalent)Languages: Fluency in English essential, both oral and written, other languages are an asset Work experience:

  • Minimum 2-4 years’ experience in R&D in biopharma/biotech industry
  • Experience in providing scientific oversight for bioanalytical projects placed at CROs
  • Experience in bioanalytical sciences in e.g. preclinical / clinical studies related to PK, immunogenicity or biomarker assays, diagnostic lab or central lab
  • od kledge of scientific best practices, GCP, GLP and kledge in regulatory guidelines
  • Has preferably worked in a global organization in a field supporting or performing drug development

 Personal skills:

  • od analytical and troubleshooting skills
  • Action/results driven
  • od communication skills, both oral and written
  • od interpersonal, networking and relationship skills required