08 ago
|
Green Life Science
|
Madrid
08 ago
Green Life Science
Madrid
Medical Director - Women's Health (Phase III)Location:UK or EU (hybrid / remote considered)Contract:Permanent, full-timeReporting to:Chief Medical OfficerThe OpportunityWe are partnering with a clinical-stage organisation advancing a late-phase programme in women's health, with a specific focus on neonatal and maternal indications.This is a Medical Director appointment with genuine scope. You will own the medical strategy behind a Phase III programme, act as the internal and external medical authority for the asset, and work directly with executive leadership as the programme moves toward registration.It is a rare combination: a therapeutic area with real unmet need, an asset in late-stage development, and a role with the seniority to shape how it gets there.What You 'll DoProvide medical leadership across the Phase III programme — protocol design, endpoint strategy, and clinical development planAct as the medical expert for the asset internally and with external stakeholders including investigators, sites, KOLs, ethics committees and regulatorsOversee medical monitoring, safety review and benefit–risk assessment throughout the trial lifecycleProvide clinical input into regulatory submissions and interactions with the MHRA, EMA and other agenciesPartner with Clinical Operations, Biostatistics, Regulatory,
Pharmacovigilance and Programme Management to keep delivery on trackBuild and maintain KOL and investigator relationships across the women 's health communityContributeto publications, advisory boards, scientific communications and congress activitySupport due diligence, medical input to business development, and evidence generation strategy as requiredWhat We 're Looking ForMD, MBBS or equivalent medical qualification, with a licence to practiseDemonstrable experience as a Medical Director (or equivalent senior medical role) within biotech, pharma or a CRODirect experience of Phase III clinical development — protocol authorship, medical monitoring and late-phase deliveryTherapeutic expertise in women 's health;
neonatal, maternal–fetal or obstetric experience is a significant advantageWorking knowledge of ICH-GCP and the EU/UK regulatory environmentBased in, and eligible to work in, the UK or EUSpecialist clinical background in obstetrics, gynaecology, neonatology or maternal–fetal medicinePrior involvement in a regulatory submission or approvalExperience in a small or scaling company where the remit extends beyond a single programmePublication record and standing within the therapeutic community
📌 Medical Director (Madrid)
🏢 Green Life Science
📍 Madrid