(Associate) Scientist nonclinical safety.

Location Gent, Belgium
Discipline: Biotechnology
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 10646
Published: about 1 month ago

For the expansion of our Nonclinical Safety team, we are looking for a motivated (associate) scientist nonclinical safety.

The (Associate) Scientist Nonclinical Safety is responsible for designing the nonclinical safety strategy for lead candidates in tight collaboration with the R&D team and will act as a study monitor for non-GLP and GLP compliant toxicity studies. He/she is also responsible for monitoring the bioanalytical part of the nonclinical safety studies in close collaboration with the bioanalytical team

YOUR RESPONSIBILITIES:

  • Advise on nonclinical safety evaluation strategy across projects
  • Design toxicity studies according to current regulatory guidelines (non-GLP and GLP compliant)
  • Coordination of internal and external study, reviewing of  study plans, study results, study reports of preclinical (safety)  studies
  • Planning and conducting PK/PD and immunogenicity assays for preclinical (safety) studies in close collaboration with the bioanalysis team
  • Responsible for all aspects of study monitoring including visits on site at the CRO
  • Identify, build and manage external collaborations
  • Integrate and present results and findings with colleagues and team members
  • Support writing of regulatory documents (e.g. IND, IMPD, Investigator’s Brochure)
  • Represent nonclinical safety in multidisciplinary project teams
  • Keep abreast of relevant literature and guidelines, be aware of scientific developments and how these might apply to argenx R&D programs

YOUR DETAILS:

  • Advanced scientific degree (Master or PhD degree) with a solid experience in the field of drug development - awareness of regulatory requirements to enable clinical trials
  • Experience in nonclinical safety testing of biologics and antibodies
  • Knowledge of quality regulations and guidelines from a GLP perspective
  • Experienced in outsourcing and managing CRO’s
  • Knowledge of bioanalytical methods (PK/PD/ADA) is an asset
  • Excellent organizational and communication skills to be an effective study monitor
  • Show proven scientific communication skills with regards to scientific report writing and informal and formal oral presentations (English)
  • Strong collaborative and interpersonal skills
  • Problem solving skills
  • Flexible; deal with continuous change
  • Fluent in English

ORGANISATION:

We are a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, we are building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development.

OFFER:

  • A competitive salary package with benefits;
  • A work environment in a human-sized, dynamic, rapidly growing biotech company

INTERESTED?

For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.