Associate Director, Study Start-up

🔥 16 minutes ago

🇺🇸 United States – Remote

💵 $182.1k - $212.9k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 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

• Drive world-class study start-up planning and execution across a global portfolio • Lead and manage a team of Study Start-up Managers • Ensure high-quality, compliant study start-up delivery across multiple programs and therapeutic areas • Drive end-to-end study start-up planning and execution from global to local • Deliver milestones on time, within budget, and in line with ICH-GCP and regulatory requirements • Provide portfolio-level oversight of study start-up performance, resourcing, and delivery metrics • Escalate risks with solution-focused recommendations • Build team capability through coaching, mentoring, performance management, and role modelling best practices • Partner with functional and hub leaders to strengthen study start-up capabilities, ways of working, and operational readiness • Own and embed study start-up business processes • Deliver training, knowledge sharing, and continuous improvement • Foster a collaborative, high-engagement culture • Contribute to the evolution of the Study Start-up Hub model and future ways of working

🎯 Requirements

• Pharma and clinical trial processes and operations expertise • Experience leading and managing global teams • Project management experience • Doctorate degree and 3 years of clinical execution experience OR Master’s degree and 7 years of clinical execution experience OR Bachelor’s degree and 9 years of clinical execution experience OR Associate’s degree and 12 years of clinical execution experience OR high school diploma/GED and 14 years of clinical execution experience • Minimum of 3 years’ experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources • Managerial experience may run concurrently with the required technical experience • 7 years’ work experience in the life sciences industry, particularly clinical trial work, including 5 years of biopharmaceutical clinical research experience at a biotech or pharmaceutical company (preferred) • Experience managing multiple teams/direct reports across multiple clinical functions (preferred) • No prior Veeva experience required

🏖️ Benefits

• Comprehensive employee benefits package • Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible • Career development opportunities • Work/life balance support