[Hiring] Senior Director, Observational Research @Amgen

Role Description

Join Amgen’s Mission of Serving Patients. The Senior Director, Observational Research is a global leadership role within Clinical Program Strategy & Operations (CPSO), providing leadership for the Observational Research function and serving as the global clinical operational leader for Amgen's observational research evidence generation portfolio.

• Lead clinical operational strategy and execution across the Observational Research portfolio, ensuring alignment with product evidence generation objectives, Clinical Development Plans (CDPs), and Evidence Generation Plans (EGPs).
• Translate evidence generation strategies into operationally feasible delivery models supporting observational research, pragmatic clinical trials, and other fit-for-purpose evidence generation approaches.
• Lead portfolio operational planning, execution, governance, and performance across all Observational Research activities.
• Direct operational input into Evidence Generation Plans, Key Design Elements (KDEs), protocols, feasibility assessments, and study operational documentation.
• Develop portfolio operational plans, timelines, resource forecasts, and budget strategies in collaboration with Product Teams and Finance.
• Lead portfolio risk identification, mitigation planning, and operational issue resolution throughout evidence generation planning and execution.
• Establish standardized clinical operational approaches that support consistency, quality, and execution across the portfolio.
• 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 cross-functional operational reviews.
• Establish strategic partnerships with the Center for Observational Research (CfOR) to ensure effective translation of scientific evidence generation strategies into operational execution.
• Partner with Regional and Country Operations to ensure operational feasibility, regional insight, and consistent global execution.
• Lead inspection readiness, audit preparedness, and implementation of corrective and preventive actions across the function.
• Direct portfolio operational performance monitoring, enrollment strategy, recruitment forecasting, and delivery metrics.
• Lead organizational design, workforce planning, and succession planning for the Real-World Evidence Clinical Operations function.
• Develop organizational capability through leadership development, coaching, performance management, and competency development.
• Allocate functional resources to support portfolio priorities and evolving evidence generation requirements.
• Establish functional priorities, operating principles, and standardized operational practices across the organization.
• Drive operational excellence through continuous improvement initiatives, operational innovation, and adoption of scalable delivery models.
• Evaluate emerging operational approaches, technologies, and digital capabilities that strengthen portfolio execution.
• Represent Clinical Program Strategy & Operations in cross-functional initiatives supporting operational excellence across Global Development Operations.
• Foster an inclusive, collaborative, and high-performing organizational culture that promotes accountability, innovation, and continuous learning.
• Drive continuous evaluation and evolution of the Observational Research capability to support future evidence generation methodologies.

Qualifications

• Doctorate degree and 5 years of clinical research, clinical operations, and/or real-world evidence experience OR
• Master's degree and 9 years of clinical research, clinical operations, and/or real-world evidence experience OR
• Bachelor's degree and 11 years of clinical research, clinical operations, and/or real-world evidence experience.
• A minimum of 5 years of direct people management and/or leadership experience leading global teams, programs, portfolios, or organizational functions.

Requirements

• Advanced degree (MD, DO, PhD, PharmD, or Master's degree in a scientific, healthcare, or related discipline).
• 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, in particular, 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 Contract Research Organizations (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, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Company Description

Amgen is dedicated to improving the quality of life for people around the world, fostering an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.