Clinical Development Senior Managers

Job Purpose

Coordinate and manage the clinical development of one or more candidate ASCIs, including region(s)/countrie(s) selection, selection of investigators, setting up of the development plan, design of clinical studies, analysis and data reporting and responsibility of the clinical reports.

Be one of the lead representatives with the health authorities, Key Opinion Leaders and clinical cooperative groups for cancer ASCIs in early clinical development.

Participate to medical discussions at regional and international advisory board meetings.
Manage budgets, resources and timing for clinical activities in collaboration with the Clinical Operations.

Actively participate to the Clinical Project Team for the ASCI(s) in development.

Be one of the lead representatives of the Clinical R&D Team within the Early Project Team.
As such, the candidate will actively participate to the global strategy of clinical development of cancer ASCIs and the Cancer Antigens portfolio.

Provide scientific and medical support for the project team(s), the marketing teams and GSK Local Operating Units.

Take part in international scientific meetings in the cancer domain.

Responsible for the medical review of all medical information such as CME events, new data, medical publications or educational slides.
Carry out, and/or help to write scientific articles, about GSK Biologcals activities in the ASCI domain.

Maintain an objective and continuous ‘up and downstream’ communication of information relating to clinical activities within the ASCI domain.

Active control of timing and milestones in agreement with Management.

Profile

• MD or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology, or diseases (oncology, chronic disorders, ...)
• Proven expertise in clinical research with international Good Clinical Practice Guidelines, basic knowledge of human experimentation laws and regulations.
• Basic mastery of epidemiological and statistical tools
• Basic understanding of GSK Bio and GSK Pharma organization
• Basic technical writing and teaching skills; good stage presence for public speaking
• Basic capability to manage people and budget
• Starting level of leadership of small teams under stress
• Strong technical, statistical and computer skills and the ability to interpret complex clinical data and experimental results.
• Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy.