06 ago
|
Green Life Science
|
España
06 ago
Green Life Science
España
ppMedical Director - Women's Health (Phase III) /ppstrongLocation: /strong UK or EU (hybrid / remote considered) /ppstrongContract: /strong Permanent, full-time /ppstrongReporting to: /strong Chief Medical Officer /ppThe Opportunity /ppWe 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. /ppThis 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. /ppIt 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. /ph3What You'll Do /h3ulliProvide medical leadership across the Phase III programme — protocol design, endpoint strategy, and clinical development plan /liliAct as the medical expert for the asset internally and with external stakeholders including investigators, sites, KOLs, ethics committees and regulators /liliOversee medical monitoring, safety review and benefit–risk assessment throughout the trial lifecycle /liliProvide clinical input into regulatory submissions and interactions with the MHRA, EMA and other agencies /liliPartner with Clinical Operations, Biostatistics, Regulatory,
Pharmacovigilance and Programme Management to keep delivery on track /liliBuild and maintain KOL and investigator relationships across the women's health community /liliContribute to publications, advisory boards, scientific communications and congress activity /liliSupport due diligence, medical input to business development, and evidence generation strategy as required /li /ulh3What We're Looking For /h3ulliMD, MBBS or equivalent medical qualification, with a licence to practise /liliDemonstrable experience as a Medical Director (or equivalent senior medical role) within biotech, pharma or a CRO /liliDirect experience of Phase III clinical development — protocol authorship, medical monitoring and late-phase delivery /liliTherapeutic expertise in women's health; neonatal, maternal–fetal or obstetric experience is a significant advantage /liliWorking knowledge of ICH-GCP and the EU/UK regulatory environment /liliBased in, and eligible to work in, the UK or EU /liliSpecialist clinical background in obstetrics, gynaecology, neonatology or maternal–fetal medicine /liliPrior involvement in a regulatory submission or approval /liliExperience in a small or scaling company where the remit extends beyond a single programme /liliPublication record and standing within the therapeutic community /li /ul /p #J-18808-Ljbffr
📌 Medical Director (España)
🏢 Green Life Science
📍 España