Medical Associate Director – Clinical Development
Core
Lead clinical development strategy and medical leadership for late-stage Phase 2 and 3 studies in rare metabolic diseases, oncology, neurology, and immunology.
Role type
Senior IC Medical Associate Director (Clinical Development)
Builds
Integrated clinical development plans, regulatory submissions, and clinical protocols for rare disease treatments.
Domain
Biopharmaceuticals / Rare Diseases / Clinical Pharmacology
Required skills
Medical degree (MBBS/MBChB) with GMC registration, Clinical pharmacology expertise, Rare disease clinical development experience, FDA interaction experience, ICH-GCP guidelines knowledge, Study design for small populations
Preferred skills
Clinical training in metabolic medicine/paediatrics/neurology, Experience with natural history data and adaptive designs, Experience designing clinical pharmacology studies
Technologies
FDA, EMA, ICH guidelines, PK/PD modelling tools
Responsibilities
Lead clinical development strategy and define study objectives, Act as sponsor medical lead for assigned programmes, Own medical content for protocols and regulatory submissions, Lead scientific engagement with investigators and advisory boards, Lead clinical pharmacology including dose selection and PK/PD analysis, Partner with Pharmacovigilance on safety signal evaluation
Seniority
Senior, hands-on IC