Director, Study Evidence – Readiness

🕒 Novembro 3

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $185.847 - $251.440 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Amgen

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1980

🏥 Saúde

🧬 Biotecnologia

💊 Farmacêutico

💰 $28.500.000.000 Post-IPO Debt em 2022-12

Healthcare • Biotechnology • Pharmaceuticals

A Amgen está comprometida a liberar o potencial da biologia para pacientes que sofrem de doenças graves, descobrindo, desenvolvendo, fabricando e fornecendo terapias humanas inovadoras. Esta abordagem começa utilizando ferramentas como genética humana avançada para desvendar as complexidades das doenças e entender os fundamentos da biologia humana.

Descrição

• Lead the Study Evidence and Readiness function, encompassing TMF Operations and Inspection Readiness • Set the strategy and priorities for TMF Operations and Inspection Readiness • Lead and develop global teams, including line management of Inspection Readiness Senior Managers and Managers • Set goals, manage performance and engagement, and build succession and capability plans • Provide integrated oversight of TMF health, critical evidence, inspection readiness, and material evidence gaps across the study portfolio • Establish metrics, thresholds, and escalation recommendations • Plan and manage departmental structure, capacity, resources, budget, suppliers, training, and business continuity • Lead improvement initiatives strengthening evidence quality, completeness, retrievability, and readiness • Represent the function in process improvement, standards development, and integration work • Develop and maintain TMF and inspection-readiness processes, policies, SOPs, work instructions, and related materials • Partner cross-functionally to resolve evidence issues, interpret trends, apply root-cause insights, and drive sustainable improvement • Provide leadership reporting on evidence health, readiness risks, remediation progress, and portfolio trends • Contribute to leadership forums and governance committees • Support audits and inspections, including preparation, response support, and lessons learned • Build relationships with internal and external experts

🎯 Requisitos

• Doctorate degree & 4 years of directly related experience or equivalent OR Master’s degree & 8 years of directly related experience or equivalent OR Bachelor’s degree & 10 years of directly related experience or equivalent • 4 years of direct managerial and/or leadership experience or equivalent • PhD, PharmD, MSc, BSc, or RN qualification preferred • 11 years of work experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO preferred • Leadership experience managing direct reports, including management-level staff • Experience in TMF operations and inspection readiness, preparation, inspection support, or response • Experience managing or overseeing external clinical research vendors • Knowledge of global GCP and regulatory expectations for clinical trial conduct, TMF records, and inspection readiness • Knowledge of risk-based oversight, evidence health, resource planning, and organizational capacity • Experience leading cross-functional work in a matrix organization, including projects, budgets, timelines, and quality metrics • Ability to build relationships, lead change, develop high-performing teams, and communicate clearly • Sponsorship for this role is not guaranteed

🏖️ Benefícios

• 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 • Work/life balance • Financial plans with opportunities to save towards retirement or other goals

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