Senior Director, Observational Research, CPSO

Amgen; United States; Remote; USD 204,000 - 277,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Time-off plans

Flexible work models

Job summary

Amgen is seeking a Senior Director of Observational Research within Clinical Program Strategy & Operations to lead the Observational Research portfolio globally. You will drive operational strategy, governance, and delivery across real-world evidence projects, pragmatic trials, and related evidence-generation activities.

You will partner with Product Teams, CfOR, and regional operations to implement scalable delivery models, ensure quality, and align with CDPs and EGPs.

Qualifications

• Doctorate degree and 5+ years of clinical research, clinical operations, and/or real-world evidence experience; or
• Master's degree and 9 years; or
• Bachelor's degree and 11 years in the field.

Responsibilities

• Lead clinical operational strategy and execution across the Observational Research portfolio.
• Translate evidence generation strategies into operational delivery models for observational research and pragmatic trials.
• Lead portfolio planning, governance, and performance across all Observational Research activities.
• Direct input into Evidence Generation Plans, KDEs, protocols, feasibility assessments, and study docs.
• Develop portfolio plans, timelines, resource forecasts, and budget strategies with Product Teams and Finance.

Skills

Observational research

Clinical operations

Global leadership

People management

Strategic planning

Education

Doctorate degree

Master's degree

Bachelor's degree

Job description

Career Category Clinical Job Description

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Director, Observational Research, CPSO

What you will do Let’s do this. Let’s change the world. 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.

The role leads clinical operational strategy and execution across observational research, pragmatic clinical trials, and other fit-for-purpose evidence generation approaches, ensuring operational delivery aligns with product evidence generation objectives and Global Development Operations (GDO) standards.

Working in partnership with Product Teams, Evidence Generation Teams, the Center for Observational Research (CfOR), Global Medical Organization, Regional and Country Operations, and other GDO functions, the Senior Director translates evidence generation strategies into operationally robust delivery models that support quality, efficiency, and execution throughout the product lifecycle.

As the functional leader for Observational Research, the Senior Director establishes the operating model, develops organizational capability, leads workforce and succession planning, and drives continuous operational improvement while leveraging existing GDO governance, systems, and quality standards.

Responsibilities:

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.

Relationships/Reporting LineReports to: · Clinical Program Strategy & Operations Therapeutic Area HeadDirect Reports: · Associate Directors, Senior Managers and other Observational Research staff, as appropriate.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic 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

In addition to meeting one of the above requirements, a minimum of 5 years of direct people management and/or leadership experience leading global teams, programs, portfolios, or organizational functions. Leadership experience may run concurrently with the required technical experience.

Preferred Qualifications:

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.

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Base Salary Range: $204,432-276,584

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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.

Application deadlineAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer.

We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.

We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.

Salary Range 204,431.80USD -276,584.20 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen