Senior Director, Clinical Risk & Insights

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🇺🇸 United States – Remote

💵 $204.4k - $276.6k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• 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

• 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

• 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

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