Senior Director, Safety Scientist
Core
Provide scientific leadership for safety surveillance and risk management across a clinical-stage biopharmaceutical portfolio, leading signal detection, benefit-risk assessment, and regulatory safety document authoring.
Role type
Senior Director, Safety Scientist (Clinical Development)
Builds
Safety strategies, risk management plans, and regulatory submissions for investigational medicines targeting Wnt/β-catenin pathway diseases.
Domain
Biopharmaceuticals / Oncology / Rare Disease / Immunology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance leadership, signal detection and management, benefit-risk assessment, MedDRA coding, regulatory document authoring, cross-functional stakeholder influence, safety data visualization
Preferred skills
Oncology, rare disease, or immunology therapeutic area expertise, AI tool proficiency for safety workflows
Technologies
Spotfire, MedDRA, Standardized MedDRA Queries (SMQs)
Responsibilities
Lead safety science activities and author Safety Surveillance Plans (SSPs); Perform signal detection, management, and literature surveillance; Author Signal Analysis Reports (SARs) and Development Risk Management Plans (dRMPs); Partner with stakeholders to leverage visualization tools for safety analysis; Prepare presentations for Drug Safety Monitoring Team (DSMT) meetings; Contribute to Investigator's Brochures, clinical protocols, and DSURs; Update Safety Science SOPs and support responses to health authorities.
Seniority
Senior Director, strategic leadership & cross-functional influence
