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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Risk Management and Root Cause Analysis, with a strong focus on systemic investigation and risk intelligence. Proven ability to lead teams, manage resources, and drive cross-functional improvements in biopharmaceutical clinical research.
Highest-signal resume keywords
Clinical Risk ManagementRoot Cause Analysis (RCA)Biopharmaceutical Clinical ResearchLeadership ExperienceOperational Excellence
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Root Cause AnalysisClinical Risk ManagementStudy Risk AssessmentsMitigation StrategiesQuality Tolerance Limits (QTLs)Key Risk Indicators (KRIs)Quality Event AnalysisAudit Inspection TrendsContinuous ImprovementBudget Management
Soft Skills
CoachingRelationship BuildingStrategic ThinkingDecision MakingCross-Functional Collaboration
Tools & Technologies
Analytics ToolsAutomation ToolsKnowledge Management Tools
Certifications & Qualifications
Doctorate DegreeMaster's DegreeM.D.D.O.PhDPharmD
Industry Keywords
Life SciencesClinical ResearchRBQMGDOGlobal Clinical ComplianceStudy Delivery TeamsR&D Quality
About the role
Key responsibilities & impact- Lead Clinical Risk & Insights as a capability focused on Root Cause Analysis, systemic investigation, and clinical execution risk intelligence
- Set the GDO-wide RCA approach and integrate systemic learning with portfolio risk intelligence and the strategic direction of RBQM
- Set RCA methodology, investigation standards, guidance, and capability materials
- Lead complex investigations and coach teams to identify systemic causes and prevent recurrence
- Own triage and executive escalation of significant, complex, recurring, and cross-portfolio clinical execution issues
- Prioritize and direct RCA support
- Provide clinical risk insight, systemic learning, trend reports, and decision briefs to Management Review, CTCC, and CPSO leadership forums
- Challenge superficial root causes and ineffective CAPAs; recommend CAPA effectiveness actions, control redesign, intervention, or senior sponsorship
- Sponsor cross-functional improvement and embed risk-informed execution
- Sponsor the RBQM strategy and maturity roadmap
- Lead and develop the department; set strategy and priorities, manage resources, budget, talent, and external expertise
- Build relationships across Global Clinical Compliance & Support, Study Delivery Teams, CPSO, GDO, R&D Quality, global networks, and external partners
- Contribute to relevant governance and standards
Requirements
What you’ll need- Doctorate degree + 4 years directly related experience, or Master’s degree + 8 years directly related experience, or Bachelor’s degree + 10 years directly related experience
- 4 years direct managerial and/or leadership experience
- M.D., D.O., PhD, PharmD, or Master’s degree preferred
- 11 years of experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research preferred
- Experience managing direct reports, including management-level staff
- Clinical risk management or RBQM experience, including study risk assessments, mitigation strategies, Critical to Quality (CtQ) factors, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs)
- Experience analyzing quality event, audit, inspection, and readiness trends
- Experience in operational excellence, continuous improvement, or quality intelligence
- Experience with analytics, automation, or knowledge-management tools
- Experience with budget, resource, and organizational capacity management
- Sponsorship for this role is not guaranteed
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Financial plans with opportunities to save towards retirement or other goals
- Work/life balance support
- Reasonable accommodations for applicants and employees with disabilities