Associate Dir. Cross TA Risk Management

Associate Director, Cross Therapeutic Area (TA) Clinical Risk Management (R&D Quality CRM)

Responsibilities:

• Coordinate identification, assessment, and mitigation of quality risks impacting trial data integrity, patient safety, wellbeing, and rights.
• Execute data-driven, risk-based clinical trial/program oversight to ensure quality execution, regulatory/internal compliance, and inspection readiness.
• Independently participate in study activities; identify/assess key protocol/set-up risks and advise on mitigation for complex trials/compounds/programs.
• Lead regular reviews of risk areas with Risk Owners to track mitigation progress, reduce risks, and identify new/additional mitigation needs.
• Maintain Clinical Quality Plans (CQP) in the quality repository to support progress reviews.
• Drive quality risk monitoring reviews and coach others.
• Communicate/facilitate risk updates via Quality Working Groups/Governance Fora.
• Develop consistent interpretation for issues requiring quality investigations.
• Provide guidance/escalate significant quality issues (SQI) and support CAPA plans and effectiveness checks.
• Drive inspection readiness: develop inspection narratives, prepare sites, ensure key documents/records availability, and coordinate mock inspections with Regulatory Compliance.
• Support Investigator/Sponsor-Monitor/third-party inspections (including post-inspection support).
• Provide independent advice on research quality/compliance; participate in cross-functional working groups to refine processes/tools.
• Provide training and coaching to peers and new employees.

Qualifications:

• Bachelor’s degree (scientific/medical/related) required.
• 8+ years healthcare industry experience required.
• Proven strong GCP Quality and/or clinical trials experience required.
• Excellent oral/written interpersonal communication; cross-functional collaboration.
• Flexibility, ability to operate in culturally diverse environments.
• Proficiency in Microsoft Office required.
• Clinical trial risk management fundamentals; ICH guidelines experience required.
• Health Authority Inspection experience (FDA/EMA/other) required.
• English proficiency required.
• Up to 10% travel.

Preferred:

• Knowledge of GMP/GLP/GPvP.
• Project planning/management.
• Escalations management and CAPA support.
• Data analytics/visualization (Tableau, Spotfire, etc.).
• Data Science and Digital Health (including RWE/RWD).

Benefits (time off):

• Vacation 120 hours/year
• Sick time 40 hours/year (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 hours (immediate) / 40 hours (extended)
• Caregiver Leave 80 hours (52-week rolling period)
• Volunteer Leave 32 hours
• Military Spouse Time-Off 80 hours/year