Associate Dir. Cross TA Risk Management

Associate Director, Cross Therapeutic Area (TA) Clinical Risk Management — R&D Quality CRM. Coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety, well‑being, and rights; execute data‑driven, risk‑based oversight; support quality execution, regulatory compliance, and inspection readiness. Key Responsibilities Identify and assess key clinical protocol/set‑up risks; advise on mitigations. Lead regular review of risk areas with Risk Owners; track mitigation progress; identify new risks. Maintain Clinical Quality Plans (CQP) in quality repository. Drive quality risk monitoring reviews and coach others. Communicate risk updates via Quality Working Groups and Governance Fora. Highlight systemic risks; ensure consistent interpretation of quality investigation issues. Guide significant quality issues (SQI) and escalate to senior R&D management. Advise on CAPA plans and Effectiveness Checks (self‑identified, inspection, audit). Drive inspection readiness (inspection narratives, site readiness, documents/records; coordinate mock inspections). Support investigator/sponsor‑monitor/third‑party inspections (including post‑inspection). Provide independent advice on research quality/compliance; participate in cross‑functional working groups. Train and coach peers/new employees. Qualifications (Required) Bachelor’s degree (scientific/medical/related). 8+ years in healthcare industry. Strong GCP Quality and/or clinical trials experience. Interpersonal and oral/written communication skills. Flexibility; ability to work across culturally diverse styles. Microsoft Office proficiency. Clinical trial risk management fundamentals. ICH guidelines experience. Health Authority Inspection experience (FDA/EMA/other). Proficiency speaking and writing English. Up to 10% travel (primarily domestic). Qualifications (Preferred) Knowledge of GMP/GLP/GPvP. Strong project planning/management; escalation and CAPA support. Data analytics/visualization tools (Tableau/Spotfire or similar). Data science/digital health (incl. RWE/RWD). Benefits Vacation: 120 hours/year; Sick time: 40 (CO 48; WA 56). Holiday pay (incl. Floating Holidays): 13 days/year. Work/Personal/Family Time: up to 40 hours/year. Parental Leave: 480 hours; Bereavement Leave: 240 (immediate) / 40 (extended); Caregiver Leave: 80 hours (52-week rolling); Volunteer Leave: 32 hours; Military Spouse Time-Off: 80 hours/year. Role may be posted under multiple requisition numbers; applications are considered a single submission—apply to the country-specific posting(s) aligned with preferred location(s). #J-18808-Ljbffr Scorpion Therapeutics