Stage Evidence Generation Oncology

✓ Under the oversight of the Medical Director, you contribute:

• in setting-up of global medical pre-launch activities on glioma
• to the development of MSL training materials on Vorasidenib
• proactively to coordinate global/local/network animation to address country medical strategy needs
• to review medical scientific publications & information in relation with the domain

✓ Under the oversight of the Evidence Generation Manager, autonomous & proactive contribution of the programs, from conception to realization:

• Design of clinical studies (phase IIIb and IV) and other evidence-generation programs: rationale, synopsis, protocols, technical documents…
• Involvement of experts and management of Study Steering Committee
• Sub-contracting: support drafting of the specifications & definition of deliverables, follow-up of subcontracted activities
• Analysis and interpretation the results of the study, validation of study reports
• Contribution to internal and external communication of study results (Abstracts, publications, posters…)
• For IIT Program management: review IIT concept, support affiliates in managing IIT concept in execution, prepare the overview of the IIT program
• with the key medical affairs stakeholders: medical lead, evidence generation lead, medical communication lead and publication manager
• With other departments and be their main contact for the activities you coordinate: R&D, global marketing and market access, affiliates
• With external partners: experts, cooperative groups, investigators, vendors (CROs, agencies…)

✓ Good practices:

• Regarding medico-scientific, operational, legal, regulatory, safety aspects
• In respect of budget, timelines, quality of deliverables
• In compliance with internal procedures (SOP), applicable regulation (GCP, GVP) and compliance rules (Fair Market Value).
• Strong interest for medical & scientific understanding, clinical & medical practice
• Previous experience in clinical studies management is a plus (Phase 3b, Real World Evidence, early access patient programs, IIT Program)
• Oncology therapeutic area knowledge is optional, but willingness to learn and adaptation capability is needed.
• Ability to work globally and cross functionally, and to contribute to multiple projects with strategic, analytical vision and business understanding
• Excellent communication skills in working with cross-functional and multi-cultural teams (oral and written English)
• Positive and committed attitude, solution and results driven, collaborative mindset
• Medicine or Pharmacy student or life sciences, such as biology, biochemistry, or business school with life science