Study Delivery Senior Manager – Study Delivery Lead

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $163.7k - $197.1k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Own end-to-end delivery of assigned global clinical studies, with accountability for quality, timelines, budget, and operational performance • Lead and align cross-functional study teams to deliver high-quality clinical data in line with the evidence generation strategy • Define and implement study plans covering feasibility, site selection, site engagement, recruitment and retention, and vendor delivery • Identify and manage study risks using quality-by-design and risk-based approaches to ensure participant safety and data integrity • Oversee global study execution, including enrollment, data flow, monitoring, and corrective actions • Provide leadership, direction, and escalation management to resolve complex study issues across geographies • Build partnerships with internal stakeholders and external vendors to ensure effective collaboration and performance • Champion continuous improvement, innovation, and regulatory compliance throughout clinical trial delivery

🎯 Requirements

• Doctorate degree and 2 years of Clinical Execution experience, or Master’s degree and 4 years of Clinical Execution experience, or Bachelor’s degree and 6 years of Clinical Execution experience, or Associate’s degree and 10 years of Clinical Execution experience, or high school diploma/GED and 12 years of Clinical Execution experience • 7 years’ work experience in life sciences or medically related field, including 5 years of biopharmaceutical clinical research experience obtained leading global clinical trials in a biotech, pharmaceutical or CRO company • Experience managing direct reports across multiple geographies • Experience representing a sponsor company in regulatory audit/inspections • Experience at or oversight of outside clinical research vendors, including CROs, central labs, and imaging vendors • 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 • 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 support