02 ago
|
Almirall
|
San Feliú de Llobregat
02 ago
Almirall
San Feliú de Llobregat
Mission
The Integral Clinical Development Physician is an important member of the Strategic Clinical team and the Clinical Study Teams within Global Clinical Development. This role provides medical 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.
The Clinical Development Physician may deputize as GCPL for defined parts of programs or programs of low complexity under supervision and serves as a primary source of clinical/medical accountability and oversight for the clinical study/ies.
Core Responsibilities
- Supports the Global Clinical Program Lead (GCPL) and Clinical Development Scientist (CDS) in designing clinical development plans and clinical studies
- Acts as a backup and is able to perform GCPL responsibilities under supervision for defined tasks
- 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)
- May deputize the GCPL as member of the Global Project Team
- Provides medical support to the Clinical Study Team to address questions raised by Ethics Committees as well as questions coming from 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 protoco
📌 Global Clinical Development Physician (San Feliú de Llobregat)
🏢 Almirall
📍 San Feliú de Llobregat