12 часов назад
Study Oversight Senior Manager (Biotech)
167 187 - 226 194$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Study Oversight Senior Manager (Biotech): Managing FSP resources, supplier performance, and country-level clinical trial delivery with an accent on quality oversight, capacity planning, compliance, and regulatory readiness. Focus on resolving trial delivery issues, coordinating clinical operations teams, supporting audits and inspections, and consolidating country-wide supplier trends for senior management.
Location: United States, with locations listed in Thousand Oaks, California and Washington, D.C.; flexible work models, including remote arrangements, may be available where possible.
Salary: $167,187–$226,194 annual base salary, plus eligible total rewards.
Company
Amgen is a biotechnology company developing and delivering medicines across oncology, inflammation, general medicine, and rare disease.
What you will do
- Manage FSP resources, including CRAs, CTAs, and LSOMs, to support quality, efficiency, capacity planning, and compliance.
- Oversee FSP supplier performance, study milestones, quality targets, metrics, and resource allocation from study startup through close-out.
- Identify, escalate, and resolve quality and clinical trial delivery issues, serving as a country-level escalation contact for supplier concerns.
- Mentor SOM Managers and coordinate consistent communication among SOM Managers, FSPs, sites, and global stakeholders.
- Support inspection readiness, site-level audits, regulatory inspections, investigator site relationships, and occasional on-site quality visits.
- Consolidate country-wide FSP trends and challenges for senior management and participate in cross-functional process improvement groups.
Requirements
- Doctorate degree plus 2 years of clinical execution experience; or master’s degree plus 6 years; bachelor’s degree plus 8 years; associate degree plus 10 years; or high school diploma/GED plus 12 years.
- At least 2 years of direct people management or leadership experience managing teams, projects, programs, or resource allocation.
- Clinical execution experience in life sciences, medically related fields, clinical research, biotechnology, pharmaceuticals, or CROs.
- Experience managing multiple teams, clinical functions, or clinical trials.
- Experience overseeing clinical research suppliers such as CROs, central laboratories, or imaging suppliers.
- Understanding of local regulatory requirements for global clinical trials across relevant geographies.
Culture & Benefits
- Health, dental, vision, life, disability, and flexible spending benefits for eligible employees and dependents.
- Retirement and savings plans with company contributions, stock-based long-term incentives, and an annual bonus program.
- Time-off plans and biannual company-wide shutdowns.
- Career development opportunities and flexible work models where applicable.
- Collaborative, innovative, science-based work environment.
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