Global Clinical Development Physician

The Global 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 input and support to the study team for a given clinical development project in line with 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.

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 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; Builds relationships with external KOLs

Requirements

Medical degree; Prior experience in clinical studies, e.g. as (sub-) investigator, or industry / CRO experience; Fluency in English (written and spoken); Proficiency with MS Office

Nice to have

Specialty in dermatology; Ability to communicate information and lead presentations in scientific and clinical settings; Data analysis, communication, and presentations 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; Analytical and problem-solving mindset