Associate Dir. Cross TA Risk Management

Associate Director, Cross Therapeutic Area (TA) Clinical Risk Management (R&D Quality CRM) Job Description Works with trial/program teams to coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety/well-being, or rights. Executes data-driven, risk-based trial oversight to ensure quality execution, regulatory compliance, internal procedures, and ongoing inspection readiness. Key Responsibilities Participate independently in study activities; identify and assess key risks in protocol/set-up and advise on mitigation strategies. Lead regular review of risk areas with Risk Owners to evaluate progress, reduce risk, and identify new risks/mitigation needs. Maintain Clinical Quality Plans (CQP) in the quality repository for progress reviews of quality support services, risks, and mitigations. Drive quality risk monitoring reviews and coach others. Communicate/facilitate risk updates via Quality Working Groups/Governance Fora. Highlight systemic risks to RDQ CRM management. Ensure consistent interpretation of issues requiring quality investigations. Provide guidance for significant quality issues (SQI) and elevate SQI to senior R&D management. Advise on CAPA Plans and Effectiveness Checks (self-identified, inspection, audit). Drive inspection readiness: develop inspection narratives, prep sites, support pre-inspection visits, ensure key documents/records, coordinate mock inspections with Regulatory Compliance. Support investigator/sponsor-monitor/third-party inspections, including post-inspection support. Provide independent advice on research quality and compliance in collaboration with Quality professionals/SMEs. Participate in cross-functional working groups to refine processes/tools/systems for quality. Provide training and coaching to peers and new employees as needed. Qualifications Bachelor’s degree (scientific/medical/related) required. 8+ years in healthcare industry (pharma, CRO, and/or healthcare/hospital) required. Strong GCP Quality and/or clinical trials experience required. Excellent interpersonal and oral/written communication required. Flexibility for changing business needs required. Experience operating across culturally diverse styles/business approaches required. Proficiency in Microsoft Office required. Clinical trial risk management fundamentals required. Experience working to ICH guidelines required. Health authority inspection experience (FDA, EMA, other inspectorates) required. English speaking/writing proficiency required. Up to 10% travel (primarily domestic) required. Preferred Skills Knowledge of GMP, GLP, and/or GPvP. Strong project planning/management. Experience managing escalations and CAPA support/advisement. Data analytics/visualization tools (e.g., Tableau, Spotfire) for decision-making. Data science and digital health (incl. RWE/RWD). Benefits (time off) Vacation: 120 hours/calendar year; Sick time: 40 hours (CO: 48; WA: 56); Holiday pay incl. floating holidays: 13 days; Work/Personal/Family time: up to 40 hours; Parental leave: 480 hours; Bereavement leave: 240 hours (immediate) / 40 hours (extended); Caregiver leave: 80 hours (52-week rolling period); Volunteer leave: 32 hours; Military spouse time-off: 80 hours. Application Instructions Applies to multiple countries/requisition postings; applications considered a single submission across requisition numbers. #J-18808-Ljbffr Scorpion Therapeutics