This is a leadership position in Medical Affairs Europe. This person will actively participate in/lead a broad range of medical affairs activities, including preparation of support to investigator initiated research (IIR) programs, European medical plan and medical review of Medical Affairs and promotional materials.
- Provide European level support to the Head of European Medical Affairs.
- Drive strategy and ensure/facilitate coordination among the European countries for the planning and execution of the European medical plan.
- Budget management of medical activities related to the assigned assets and regular follow-up meetings to respect the milestones
- Medical lead of the brand team of assigned assets with active participation to regular Brand team meetings, by providing medical presentations and annual medical brand plan. Then support the implementation of European strategy in accordance with the brand plan and other functions (Commercial, Market Access, Public Affairs,…)
- Coordinate and leverage on the Solid Tumor country representatives through the Solid tumor Medical affairs Regional team (SMART) in coordination with the second Medical Director Solid Tumors
- Act as a bridge or reference point between Global Medical Affairs/Global Clinical Development/Development Operations and the European countries.
- Participate to the Strategic Focus Groups (SFGs) of assigned assets, representing the EU position and providing Regional inputs.
- Prepare for Development Review Board (DRB) meeting the consolidation of the EU position from a medical point of view in collaboration with Market Access, Regulatory and Commercial functions.
- Accountable, in collaboration with Medical Communication colleagues, for European Medical affairs activities related to the area of competence (e.g. European advisory boards, Preceptorships, speaker’s tours etc.)
- European level medical and promotional materials review for scientific/medical accuracy.
- Responsible for IIR initial screening in collaboration with the IIR Medical Director. Facilitates approval of proposed European IIR concepts through the internal review process.
- Work with the European MSL’s & affiliate Medical Directors to plan and implement strategic interactions with European KOLs.
- Develop the scientific programs for the European symposia in collaboration with the European Medical Communication colleagues, identify experts to engage and support and validate the scientific content of the symposium with support of Medical Communication, Regulatory and Legal colleagues
- Coordinate European Medical Affairs Congress support and provide and validate the medical materials for medical booth at congresses
- Support the Early Access Programs of assigned assets in collaboration with Medical Operation colleagues.
- Ensuring compliance with rules and regulations applicable to medical affairs activities in Europe.
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines
- MD or MD/PhD with 5+ years in academic, clinical, industry setting required.
- Oncology/Hematology experience required.
- Familiarity with GCP/ICH/FDA/EMA requirements as well as clinical trial design, biostatistics, medical writing, product safety, healthcare compliance and regulatory affairs.
- Strong interpersonal, verbal and written communication skills. Strong public speaking skills.
- Excellent leadership and management skills.
- Ability to influence and work effectively across functions and operate in a matrix environment.
- Ability to travel 30-35% of working time