Senior Director, Observational Research

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🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

💵 $204.4k - $276.6k / year

⏰ Full Time

🟠 Senior

👔 Director

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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

• Lead clinical operational strategy and execution across the Observational Research portfolio • Translate evidence generation strategies into operationally feasible delivery models • Lead portfolio operational planning, execution, governance, and performance • Provide operational input into Evidence Generation Plans, Key Design Elements, protocols, feasibility assessments, and study documentation • Develop operational plans, timelines, resource forecasts, and budget strategies • Lead portfolio risk identification, mitigation planning, and operational issue resolution • Establish standardized clinical operational approaches supporting consistency, quality, and execution • Lead vendor strategy, outsourcing models, governance, and performance management for Real-World Evidence Clinical Operations • Represent Real-World Evidence Clinical Operations within Product Teams, governance forums, and operational reviews • Partner with the Center for Observational Research and Regional and Country Operations • Lead inspection readiness, audit preparedness, and corrective and preventive actions • Direct portfolio performance monitoring, enrollment strategy, recruitment forecasting, and delivery metrics • Lead organizational design, workforce planning, and succession planning • Develop organizational capability through leadership development, coaching, performance management, and competency development • Allocate functional resources and establish priorities, operating principles, and standardized practices • Drive operational excellence, innovation, continuous improvement, and adoption of scalable delivery models • Evaluate emerging operational approaches, technologies, and digital capabilities • Foster an inclusive, collaborative, high-performing culture and evolve Observational Research capabilities

🎯 Requirements

• Doctorate degree and 5 years of clinical research, clinical operations, and/or real-world evidence experience OR Master's degree and 9 years of such experience OR Bachelor's degree and 11 years of such experience • Minimum of 5 years of direct people management and/or leadership experience leading global teams, programs, portfolios, or organizational functions • 10+ years of experience within the biopharmaceutical industry, including significant experience supporting global clinical development and evidence generation • Demonstrated leadership of global clinical operations across complex development programs and/or evidence generation portfolios • Experience leading observational research, pragmatic clinical trials, and other real-world evidence generation approaches within a pharmaceutical or biotechnology environment • Experience developing and implementing clinical operational strategies across global, cross-functional organizations • Experience leading global, matrixed organizations with responsibility for organizational capability, workforce planning, and talent development • Experience overseeing external service providers, including CROs, strategic functional service providers, technology partners, and other outsourced operational models • Experience leading organizational change, operational transformation, and continuous improvement initiatives • Demonstrated success representing clinical operations within senior governance, portfolio, and cross-functional leadership forums

🏖️ 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 • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance support

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