Clinical Scientist
Il y a 7 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, Data Management, Statistics, Drug Safety, Regulatory Affairs, Clinical Quality Assurance, Translational Medicine, Market Research and Project Management).
He/she participates on 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:
- Contact Key Opinion Leaders and perform/participate in advisory board meetings, in collaboration with the Clinical Research Physician (CRP)-
- Participate in the outreach for medical and regulatory advice Address any clinical / scientific issues arising from regulatory authorities and ethics committees.- Develop and conduct trial specific biomarker and translational research- 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.- 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.- 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.- Perform ongoing resolution of issues arising from patient clinical management e.g. patient eligibility and study conduct.- Provide input into safety data reconciliation.- Assist in the identification and review of protocol deviations during study conduct.- 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 neurology, neurodegeneration, and/or immunology- Knowledge of clinical research, including basic statistics, pharmacodynamics and pharmacokinetics;-
- 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, MD);- Knowledge of GCP and ICH Guidelines is a plus;- Experience in clinical research development or equivalent is a plus
**Offer**:
- A competitive salary package with extensive benefits;- A work environment in a successful, dynamic, rapidly growing biotech company.
LI-Onsite
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