07 ago
|
Green Life Science
|
España
07 ago
Green Life Science
España
Medical Director - Women's Health (Phase III) Location: UK or EU (hybrid / remote considered) Contract: Permanent, full-time Reporting to: Chief Medical Officer The Opportunity We 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 Do Provide medical leadership across the Phase III programme — protocol design, endpoint strategy, and clinical development plan Act as the medical expert for the asset internally and with external stakeholders including investigators, sites, KOLs, ethics committees and regulators Oversee medical monitoring, safety review and benefit–risk assessment throughout the trial lifecycle Provide clinical input into regulatory submissions and interactions with the MHRA, EMA and other agencies Partner with Clinical Operations, Biostatistics, Regulatory,
Pharmacovigilance and Programme Management to keep delivery on track Build and maintain KOL and investigator relationships across the women 's health community Contribute to publications, advisory boards, scientific communications and congress activity Support due diligence, medical input to business development, and evidence generation strategy as required What We 're Looking For MD, MBBS or equivalent medical qualification, with a licence to practise Demonstrable experience as a Medical Director (or equivalent senior medical role) within biotech, pharma or a CRO Direct experience of Phase III clinical development — protocol authorship, medical monitoring and late-phase delivery Therapeutic expertise in women 's health;
neonatal, maternal–fetal or obstetric experience is a significant advantage Working knowledge of ICH-GCP and the EU/UK regulatory environment Based in, and eligible to work in, the UK or EU Specialist clinical background in obstetrics, gynaecology, neonatology or maternal–fetal medicine Prior involvement in a regulatory submission or approval Experience in a small or scaling company where the remit extends beyond a single programme Publication record and standing within the therapeutic community #J-18808-Ljbffr
📌 Medical Director (España)
🏢 Green Life Science
📍 España