Job Description
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Mission
Core member of the Global Project Team and Strategic Clinical Team.
Supports the GCPL on the design of clinical development plans (focus on critical review of studies from competitors and aiming to optimize the clinical quality of the clinical design) for internal assets.
Provides regular scientific disease state updates, monitoring of the scientific aspects of the competitive landscape (maintain the scientific updates of competitors in targeted indications which will be the basis for Early Disease Roadmaps (EDR) and Target Product Profile (TPP) definition).
Core Member of Clinical Study Team
Works cross-functionally within project / study teams to ensure the clinical strategy is translated into the development of the study concept document / synopsis, study protocol, and related documents.
Leads the development of the clinical study synopsis with guidance from GCPLs or delegate and is responsible for the accuracy of the scientific content of the study protocol, amendments, CSRs, ICF, CRF, as well as scientific / clinical content of key internal or external project-related documents (e.g., IB, Biomarker Strategy, briefing package for regulatory authorities, responses to Health Authorities for registration purposes and clinical studies approvals, ISE, ISS, publication).
Participates in Data Monitoring Committees
Provides support for the definition and review of protocol deviations and leads the preparation of the conventions for the DRM. Supports the GCPL in data analysis and data review.
Participates in data analysis and provides support for content proposals for publications.
Education
Bachelor’s degree in life sciences or equivalent (e.g., Pharmacy, Biology, Molecular Medicine, Bioengineering).
Advanced Degree (PhD or master’s degree in Pharmaceutical Medicine) valuable.
Prior experience in immunology or dermatology may also be considered.
More than 3 years of Pharmaceutical Industry experience in drug development, including experience in Health Authorities consultancies and contributions to MAA submission to the Health Authorities.
Demonstrates understanding of methodology in the design, conduct, review, interpretation, and presentation of clinical research.
Fluency in English (written and spoken), proficiency with MS Office.
Specific Knowledge
Data analysis, communication, and presentation skills in team settings and in formal presentations to leadership committees both internally and externally.
Leadership skills with the ability to influence others and drive consensus building.
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