Chief Medical Officer

Il y a 4 heures

OttigniesLouvainlaNeuve, Wallonie, Belgique Inteliphage Temps plein

Working closely with the CEO, CBO and CSO, you integrate clinical medicine, clinical operations, regulatory medicine, pharmacovigilance, medical affairs, publications and commercial medical education. You will also be a visible external representative of Inteliphage in hospitals, clinical societies and the international infectious-disease.

What your days could look like

Clinical strategy completion and execution

  • Lead and work closely with our Clinical Advisory Board to define and finalise key clinical questions, including patient populations, sub-indication grouping, endpoints, biomarkers, timing and practical implementation.
  • Translate the clinical strategy into regulator-ready and site-executable studies.
  • Maintain a coherent route from First-in-Human studies to pivotal development and registration.

Medical affairs and external clinical leadership

  • Build Inteliphage’s medical affairs capability.
  • Develop relationships with KOLs, regulators, investigators, societies, hospitals and clinical microbiology networks.
  • Represent Inteliphage at scientific congresses, advisory boards and expert meetings.
  • Lead publication planning and timely dissemination of clinical results in peer-reviewed literature.

Clinical development leadership

  • Finalize the Clinical Development Plan, Target Product Profiles and indication-specific evidence plans.
  • Lead protocol development, investigator brochures, clinical sections of regulatory dossiers and clinical study reports.
  • Oversee Phase I–III execution, including medical monitoring, eligibility decisions, endpoint interpretation and benefit-risk assessment.
  • Ensure strong interfaces with clinical operations, statistics, data management, pharmacology, CMC and regulatory affairs.

Medical education for Business Development teams

  • Design and deliver structured medical training for Business Development teams.
  • Ensure teams understand disease pathways, unmet need, PTMP mechanism and use, clinical evidence, appropriate scientific claims and escalation of medical questions.
  • Develop field medical materials and maintain scientific consistency in hospital-facing interactions.

Patient safety and regulatory medicine

  • Provide medical oversight of pharmacovigilance and safety management.
  • Lead medical contributions to EMA and other authority interactions, ethics committees and clinical trial applications.
  • Maintain an evidence-based benefit-risk framework across the product lifecycle.

Medical strategy and governance

  • Own and execute the company-wide medical strategy.
  • Establish medical governance, safety escalation, evidence review and protocol decision processes.
  • Advise the Executive Leadership Team and Board on medical risk, opportunity and development choices.

European clinical partnerships and programme financing

  • Convert the existing Clinical Advisory Board and hospital network into trial-specific European consortia for BJI, acute and chronic LRTI.
  • Own the clinical rationale, protocol architecture, site model, recruitment assumptions and clinical budgets used in Horizon Europe, IHI and complementary funding applications.
  • Identify and medically qualify national, disease-specific and investigator-led funding opportunities that can finance defined components of the five-trial program.
  • Ensure that consortium agreements, clinical trial agreements and data-access arrangements provide Inteliphage with the rights required to use the complete clinical evidence package in regulatory submissions.
  • Work with the CEO, CBO, CSO, Finance, Regulatory and program-management functions to elaborate and monitor funding plans

What you bring to the table
Education and clinical credentials

  • Medical degree with specialist training in infectious diseases strongly preferred.
  • Internal medicine, clinical microbiology, pulmonology, intensive care or another relevant specialty may be considered if combined with deep anti-infective expertise.
  • PhD, clinical research doctorate or equivalent academic track record is highly desirable.

Professional experience

  • Typically 10+ years of combined clinical, academic and/or pharmaceutical development experience.
  • Experience designing and leading multicenter interventional studies, preferably in infectious diseases or anti-infectives.
  • Experience building multinational investigator networks and contributing to public, charitable or collaborative clinical-research funding applications is strongly preferred.
  • Demonstrated clinical development experience from early phase through pivotal studies and registration.
  • Experience with EMA a