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Clinical Development Physician
hace 3 meses
Clinical Development Physician is an important part of Global Study Teams within Global Clinical Development. Provides medical input and support to the study team for a given clinical development project in line within defined clinical development strategy, Target Product Profile (TPP) and target labelling, in collaboration with the cross functional teams and under supervision of a Global Clinical Program Lead (GCPL) or a line manager. Serves as a primary source of clinical/medical accountability and oversight for the clinical study/ies.
Tasks and Responsibilities- Supports the GCPL and Clinical Development Scientist (CDS) in designing clinical development plans and clinical studies.
- Supports clinical study synopsis, study protocol, study protocol amendments elaboration in collaboration with GCPLs and CDS.
- Supports GCPL and CDS in review 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 (eg. IB, briefing package for regulatory authorities, ISE, ISS, publication).
- Provides medical support to the Clinical Study Team to address questions raised by Ethics Committees as well as questions coming form the investigators in preparation and during the study/ies conduct.
- Leads medical data review, including eligibility review and safety data review.
- Provides medical support for the protocol deviation review.
- Partners with CDS and Clinical Operations to support clinical study/ies delivery (enrollment status, eligibility criteria and adjudication for protocol violation, evaluate need for study protocol amendment/s)
- Once clinical study/ies results are available, support the GCPL and CDS in data analysis, data review and content proposals for the publications.
- Core member of the Clinical Study Team
- Medical degree.
- 1-3 years of experience
- Industry experience in drug development is a plus
- Specialty in dermatology or immunology is a plus
- Fluency in English (written and spoken)
- Proficiency with MS Office.
- Care: we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
- Courage: we challenge the status quo, we take full ownership and we learn from our success & failures
- Innovation: we put the patient and customer at the center, we create novel solutions and we empower entrepreneurial mindsets.
- Simplicity: we act decisively and avoid over-analysis, we understand why before we act and we are agile & keep things simple.
