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Clinical Scientist
il y a 1 mois
For the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals.
He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional team (that includes Clinical Operations, Medics, Data Management, Statistics, Drug Safety, Regulatory Affairs, Medical Affairs, Clinical Quality Assurance, Translational Medicine, Market Research and Project Management).
He/she participates in various committees and in the Clinical Development planning for assigned compounds in specific disease areas.
Key Accountabilities/Responsibilities:
The Clinical Scientist will have the following key responsibilities:
- Review and provide clinical and scientific input to the study protocol, Informed Consent Form (ICF), 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.
- Assist in the identification and review of protocol deviations during study conduct.
- Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct.
- Supports the development of the scientific section of study-specific guidelines.
- Provide input into safety data reconciliation.
- Ensure that clinical study milestones are aligned from a clinical / scientific perspective and consistent with the clinical program.
- Review and provide input into Clinical Study Reports.
- Review and supports external content development such as Scientific posters, manuscripts,...
- Participate in the outreach for medical and regulatory advice.
- Address any clinical / scientific issues arising from regulatory authorities and ethics committees.
- Participate and Present at external Investigator Meetings and at internal and external meetings.
- Support the study team with scientific expertise at study site initiation and subsequent motivational visits, as required.
- Contact Key Opinion Leaders and perform/participate in advisory board meetings, in collaboration with the trial physician.
- Participate as a key meeting contributor in the Clinical Trial team (CTT), DRC, Clinical Data Review Plan, Risk Management and any related meetings, as appropriate.
- Develop and conduct trial specific biomarker and translational research.
Desired Skills and Experience:
- Relevant advanced scientific or medical degree (e.g. PhD, MD).
- Profound medical/scientific knowledge, especially in the fields of neurology, neurodegeneration, and/or immunology.
- Knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics.
- Knowledge of GCP and ICH Guidelines is a plus; Experience in clinical research development or equivalent is a plus.
- Good written and oral English language skills.
- Excellent communication skills.
- Excellent interpersonal skills.
- Detail-oriented and well-organized.
Offer:
- A competitive salary package with extensive benefits.
- A work environment in a successful, dynamic, rapidly growing biotech company.
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