Associate Dir. Cross TA Risk Management

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

Job Description To Follow
The Associate Director, Cross TA Clinical Risk Management, coordinates the 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 of clinical trials/programs, compliance with regulatory requirements and internal procedures, and continued inspection readiness.

Key Responsibilities
- Independently participate in study activities; identify and assess protocol set-up risks and advise on mitigation strategies for complex trials/compounds/programs.
- Lead regular reviews of risk areas with Risk Owners to evaluate mitigation progress, reduce risk, and identify new/additional mitigation needs.
- Maintain CQP (Clinical Quality Plans) in the quality repository to support progress reviews of quality support services, risks, and mitigations.
- Independently 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.
- Guide significant quality issues (SQI) and escalate SQI to senior R&D management.
- Advise on CAPA plan development/implementation and effectiveness checks.
- Drive inspection readiness: develop inspection narratives, prepare sites, ensure availability of key documents/records, and coordinate mock inspections with Regulatory Compliance.
- Support investigator/sponsor-monitor/third-party inspections (including post-inspection).
- Provide independent research quality/compliance advice with Quality professionals/SMEs.
- Participate in cross R&D quality/cross-functional working groups to develop/refine processes/tools/systems.
- Provide training and coaching to peers and new employees.

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 to changing business needs required.
- Ability to operate across culturally diverse regional/global structures required.
- Proficiency in Microsoft Office required.
- Clinical trial risk management fundamentals required; ICH guideline experience required.
- Health Authority Inspection experience (FDA/EMA/other inspectorates) required.
- GMP/GLP/GPvP knowledge preferred.
- Strong project planning/management preferred.
- Escalation and CAPA support/advisement preferred.
- Data analytics/visualization tools (e.g., Tableau/Spotfire) preferred.
- Data Science/Digital Health and RWE/RWD preferred.
- Proficiency speaking and writing English required.
- Up to 10% travel (primarily domestic) .

Benefits
Vacation –120 hours per calendar year; Sick time –40 hours (Colorado: 48; Washington: 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; Volunteer Leave –32 hours; Military Spouse Time-Off –80 hours.