Clinical Scientist

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

Contact email: c.becker@panda-int.com
Job ref: 11054
Published: 8 days ago
We are looking for a Clinical Scientist  who is responsible for  the planning and implementation of clinical programs.

Expected to be the contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional team.

Responsibilities:
  • Participate in the Clinical Development planning for assigned compounds in specific disease areas.
  • Contact Key Opinion Leaders and perform/participate in advisory board meetings, in collaboration with the Clinical Research Physician (CRP)
  • Support the study team with scientific expertise at study site initiation and subsequent motivational visits, as required.
  • Develop the clinical scientific section of study-specific guidelines.
  • Participate in document template design and SOP writing.
  • Participate in the outreach for medical and regulatory advice Address any clinical / scientific issues arising from regulatory authorities and ethics committees.
  • Ensure that clinical study milestones are aligned from a clinical / scientific perspective and consistent with the clinical program.
  • Identify membership and provide input into the charters of the Data Monitoring Committee (DMC), Steering Committee (SC) and other committees as required.
  • Review and provide clinical input to the Statistic Analysis Plan, Monitoring Plans, Risk Management Plan, Case Report Forms (CRFs), edit specifications/checks, CRF completion guidelines, Study Charters and relevant regulatory documents, as required.
  • Participate and Present at external Investigator Meetings and at internal and external meetings.
  • Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct.
  • Perform analysis of study data in order to develop a deep scientific understanding of our drug candidates.
  • Provide input into safety data reconciliation.
  • Participate as a key meeting contributor in the DMC, SC, Clinical Data Review Plan, Risk Management and any related meetings, as appropriate.
  • Review and provide input into Clinical Study Reports and relevant clinical sections of the Investigator Brochure, as required.
     
Desired Skills And Experience
  • Profound medical/scientific knowledge, especially in the fields of immunology, neurology and/or hematology
  • Knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics;
  • Ability to analyze and assimilate technical and scientific data and to apply knowledge;
  • Knowledge of GCP and ICH Guidelines;
  • Good written and oral English language skills;
  • Excellent communication skills;
  • Excellent interpersonal skills;
  • Detail-oriented and well-organized;
  • Relevant advanced scientific or medical degree (e.g. PhD, PD);
  • Experience in clinical research development or equivalent is a plus.

INTERESTED?

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