Senior Director, Clinical Risk & Insights
About The Position
The Senior Director, Clinical Risk & Insights leads a capability focused on Root Cause Analysis (RCA), systemic investigation, and clinical execution risk intelligence. The role ensures that significant, complex, recurring, and cross-portfolio issues generate clear executive insight, informed decisions, and sustained improvement. It sets the Global Development Organization (GDO)-wide RCA approach, integrates systemic learning with portfolio risk intelligence, and provides strategic direction for Risk-Based Quality Management (RBQM). The position leads and develops the department, setting strategy and priorities while managing resources, budget, talent, and external expertise. It builds organizational RCA capability and works across clinical compliance and support, study delivery, CPSO, GDO, R&D Quality, global networks, and external partners.
Requirements
- Doctorate degree and 4 years of directly related experience, or a master’s degree and 8 years of directly related experience, or a bachelor’s degree and 10 years of directly related experience.
- At least 4 years of direct managerial and/or leadership experience.
Nice To Haves
- M.D., D.O., Ph.D., Pharm.D., or master’s degree.
- 11 years of experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research.
- 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; operational excellence, continuous improvement, or quality intelligence.
- Experience with analytics, automation, or knowledge-management tools; budget, resource, and organizational capacity management.
Responsibilities
- 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, the Clinical Trial Compliance Committee (CTCC), and CPSO leadership forums.
- Challenge superficial root causes and ineffective CAPAs; recommend CAPA effectiveness actions, control redesign, intervention, or senior sponsorship when systemic clinical execution risk is identified.
- Sponsor cross-functional improvement when system or control failures extend beyond one study or function; influence sustained change and embed risk-informed execution.
- Sponsor the RBQM strategy and maturity roadmap, connecting systemic learning and portfolio risk intelligence with prospective risk identification and future study execution.
- Lead and develop the department; set strategy and priorities, manage resources, budget, talent, and external expertise, and build organizational RCA capability.
- Build relationships across Global Clinical Compliance & Support, Study Delivery Teams (SDTs), CPSO, GDO, R&D Quality, global networks, and external partners; contribute to relevant governance and standards.
Benefits
- Health and welfare plans for staff and eligible dependents.
- Retirement and Savings Plan with company contributions.
- Group medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
- Stock-based long-term incentives.
- Award-winning time-off plans.
- Flexible work models where possible.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
