Director Reproductive Toxicologist
Core
Provide expert scientific leadership and strategic guidance on developmental and reproductive toxicology across the drug development lifecycle, from discovery to post-marketing.
Role type
Senior Reproductive Toxicologist (Strategic IC)
Builds
Development and registration strategies for innovative medicines
Domain
Pharmaceutical R&D / Regulatory Toxicology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Interpretation of developmental/reproductive/juvenile toxicology data, strategic application of global regulatory guidelines (ICH M3, S5, S6, S9, S11), experience with health authority interactions (EMA, PMDA, CDE, FDA), product labelling strategy, clinical development planning, regulatory submission support
Preferred skills
Paediatric development programme support, broad therapeutic modality exposure, innovative reproductive safety assessment approaches, external scientific working group participation
Technologies
ICH M3, ICH S5, ICH S6, ICH S9, ICH S11
Responsibilities
Provide expert interpretation of toxicology data and translate findings into development/regulatory strategy; Partner with multidisciplinary teams on clinical development plans and regulatory submissions; Advise on reproductive safety assessments and inclusion of women of childbearing potential; Design and oversee reproductive toxicology programmes; Present toxicology positions to project teams; Represent the company in external scientific forums and consortia
Seniority
Senior, strategic influence & multidisciplinary leadership