Executive Assistant

Il y a 4 heures

OttigniesLouvainlaNeuve, Wallonia, Belgique Biopark Temps plein
h3Chief Medical Officer (CMO)
- (M/F/X) Inteliphage /h3 pAs a Chief Medical Officer, you will be accountable for Inteliphage’s medical strategy and for the clinical development of its Phage Therapy Medicinal Product (PTMP) portfolio. You will convert an advanced clinical concept into executable protocols, high-quality trials, interpretable evidence and registration-ready clinical dossiers.community. /p pWorking 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. /p h3What your days could look like /h3 h3Clinical strategy completion and execution /h3 ul liLead 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. /li liTranslate the clinical strategy into regulator-ready and site-executable studies. /li liMaintain a coherent route from First-in-Human studies to pivotal development and registration. /li /ul h3Medical affairs and external clinical leadership /h3 ul liBuild Inteliphage’s medical affairs capability. /li liDevelop relationships with KOLs, regulators, investigators, societies, hospitals and clinical microbiology networks. /li liRepresent Inteliphage at scientific congresses, advisory boards and expert meetings. /li liLead publication planning and timely dissemination of clinical results in peer-reviewed literature. /li liFinalize the Clinical Development Plan, Target Product Profiles and indication-specific evidence plans. /li liLead protocol development, investigator brochures, clinical sections of regulatory dossiers and clinical study reports. /li liOversee Phase I–III execution, including medical monitoring, eligibility decisions, endpoint interpretation and benefit-risk assessment. /li liEnsure strong interfaces with clinical operations, statistics, data management, pharmacology, CMC and regulatory affairs. /li /ul h3Medical education for Business Development teams /h3 ul liDesign and deliver structured medical training for Business Development teams. /li liEnsure teams understand disease pathways, unmet need, PTMP mechanism and use, clinical evidence, appropriate scientific claims and escalation of medical questions. /li liDevelop field medical materials and maintain scientific consistency in hospital-facing interactions. /li /ul h3Patient safety and regulatory medicine /h3 ul liProvide medical oversight of pharmacovigilance and safety management. /li liLead medical contributions to EMA and other authority interactions, ethics committees and clinical trial applications. /li liMaintain an evidence-based benefit-risk framework across the product lifecycle. /li /ul h3Medical strategy and governance /h3 ul liOwn and execute the company-wide medical strategy. /li liEstablish medical governance, safety escalation, evidence review and protocol decision processes. /li liAdvise the Executive Leadership Team and Board on medical risk, opportunity and development choices. /li /ul h3European clinical partnerships and programme financing /h3 ul liConvert the existing Clinical Advisory Board and hospital network into trial-specific European consortia for BJI, acute and chronic LRTI. /li liOwn the clinical rationale, protocol architecture, site model, recruitment assumptions and clinical budgets used in Horizon Europe, IHI and complementary funding applications. /li liIdentify and medically qualify national, disease‑specific and investigator‑led funding opportunities that can finance defined components of the five‑trial program. /li liEnsure 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. /li liWork with the CEO, CBO, CSO, Finance, Regulatory and program‑management functions to elaborate and monitor funding plans /li /ul h3What you bring to the tablebr/Education and clinical credentials /h3 ul liMedical degree with specialist training in infectious diseases strongly preferred. /li liInternal medicine, clinical microbiology, pulmonology, intensive care or another relevant specialty may be considered if combined with deep anti‑infective expertise. /li liPhD, clinical research doctorate or equivalent academic track record is highly desirable. /li /ul h3Professional experience /h3 ul liTypically 10+ years of combined clinical, academic and/or pharmaceutical development experience. /li liExperience designing and leading multicenter interventional studies, preferably in infectious diseases or anti‑infectives. /li liExperience building multinational investigator networks and contributing to public, charitable or collaborati