Senior Reproductive Toxicologist - Clinical Pharmacology and Safety Sciences (CPSS)
Core
Senior Reproductive Toxicologist providing expert scientific leadership and strategic guidance on developmental, reproductive, and juvenile toxicology data to support drug development from discovery through post-marketing.
Role type
Senior IC Reproductive Toxicologist (Regulatory Toxicology)
Builds
Development and registration strategies for innovative medicines across multiple therapeutic areas and modalities
Domain
Pharmaceutical industry, Reproductive Toxicology, Regulatory Affairs
Required skills
Interpretation of developmental/reproductive/juvenile toxicology data, Strategic application of toxicology findings, Global regulatory guideline expertise (ICH M3, S5, S6, S9, S11), Health authority interaction management, Clinical development plan support, Product labelling strategy, Multidisciplinary team influence, Regulatory submission support
Preferred skills
Paediatric development programme support, Broad therapeutic modality exposure, Innovative reproductive safety assessment approaches, External scientific consortium participation
Technologies
ICH M3, ICH S5, ICH S6, ICH S9, ICH S11
Responsibilities
Provide expert interpretation of developmental, reproductive and juvenile toxicology data; 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 reproductive toxicology positions to project teams; Represent company in external scientific forums
Seniority
Senior, hands-on IC with strategic influence