Director, Study Evidence – Readiness

🕒 il y a 3 jours

🇺🇸 États-Unis – Télétravail

💵 $185 847 - $251 440 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 0%

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Amgen

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10 000+ employés

Fondée en 1980

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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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