Clinical Scientist

il y a 9 heures

Gent, Belgique Argenx Temps plein

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.

This position is based in our facilities in Zwijnaarde (Ghent, Belgium).

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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