Senior Director, Clinical Risk & Insights

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee Clinical Risk & Insights as a capability centered on Root Cause Analysis, systemic investigation, and clinical execution risk intelligence.

• Establish the GDO-wide RCA framework and align systemic learning with portfolio risk intelligence and the strategic objectives of RBQM.

• Define RCA methodology, investigation standards, guidance, and capability resources.

• Lead intricate investigations and mentor teams to discover systemic causes and avert recurrence.

• Manage triage and executive escalation of significant, complex, recurring, and cross-portfolio clinical execution challenges.

• Prioritize and direct RCA assistance.

• Deliver clinical risk insights, systemic learning, trend reports, and decision briefs to Management Review, CTCC, and CPSO leadership forums.

• Question superficial root causes and ineffective CAPAs; suggest CAPA effectiveness actions, control redesign, intervention, or senior sponsorship.

• Advocate for cross-functional improvements and integrate risk-informed execution.

• Champion the RBQM strategy and development roadmap.

• Lead and cultivate the department; establish strategy and priorities, oversee resources, budget, talent, and external expertise.

• Foster 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

• Doctorate degree with 4 years of directly related experience, or Master’s degree with 8 years of directly related experience, or Bachelor’s degree with 10 years of directly related experience.

• 4 years of direct managerial and/or leadership experience.

• M.D., D.O., PhD, PharmD, or Master’s degree is preferred.

• 11 years of experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research is preferred.

• Experience managing direct reports, including management-level personnel.

• Clinical risk management or RBQM experience, encompassing study risk assessments, mitigation strategies, Critical to Quality (CtQ) factors, Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs).

• Experience in analyzing quality event, audit, inspection, and readiness trends.

• Background in operational excellence, continuous improvement, or quality intelligence.

• Familiarity with analytics, automation, or knowledge-management tools.

• Experience with budget, resource, and organizational capacity management.

• Sponsorship for this role is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package, which includes 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 feasible.

• Opportunities for career development.

• Financial plans with options to save towards retirement or other objectives.

• Support for work/life balance.

• Reasonable accommodations for applicants and employees with disabilities.