Lets do this. Lets change the world. In this vital role, you will provide global strategic leadership for Amgens Observational Research Clinical Operations function within Clinical Program Strategy & Operations (CPSO), driving the strategy and execution of observational studies, pragmatic clinical trials, and innovative real-world evidence generation approaches. You will shape the functions operating model, capabilities, and portfolio priorities, ensuring high-quality, efficient, and compliant delivery of evidence that supports product development and patient outcomes.
Key Responsibilities
- Lead the global clinical operational strategy, planning, and execution of the Observational Research portfolio, aligning delivery with product development and evidence generation objectives.
- Translate innovative evidence generation strategies into scalable and effective operational delivery models, including observational research and pragmatic clinical trials.
- Set portfolio priorities and oversee operational governance, resource allocation, budgets, vendor strategies, risk management, and performance.
- Establish strategic partnerships with Product Teams, the Center for Observational Research (CfOR), Global Development Operations (GDO), and other cross-functional stakeholders to ensure successful portfolio execution.
- Lead and develop the Observational Research function, shaping organizational capabilities, workforce planning, talent development, and succession strategies.
- Drive operational excellence, quality, and compliance through standardized processes, inspection readiness, continuous improvement, and innovative technologies.
- Represent the function in senior leadership and governance forums, influencing strategic decisions and advancing future evidence generation capabilities.
Qualifications and skills
- Degree educated
- Extensive experience in clinical research, clinical operations, and/or real-world evidence generation, including significant experience within the biopharmaceutical industry.
- Proven leadership of global clinical operations, complex programs, and evidence generation portfolios, particularly observational research and pragmatic clinical trials.
- Strong business acumen and strategic thinking, with the ability to translate broader organizational objectives and innovative real-world evidence strategies into actionable clinical operational plans.
- Demonstrated people leadership experience, including building and developing high-performing global teams, workforce planning, and talent development.
- Strong understanding of global clinical development, evidence generation, Good Clinical Practice (GCP), and applicable regulatory and quality standards.
- Experience overseeing portfolio planning, budgets, resource allocation, operational governance, and external partnerships, including CROs and service providers.
- Proven ability to lead organizational transformation, drive innovation, and implement continuous improvement initiatives.
- Strong executive presence, communication, and influencing skills, with the ability to engage senior leadership and navigate complex, global matrix organizations.
- Strategic decision-making and problem-solving capabilities, with a focus on operational excellence, risk management, and successful portfolio delivery.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career., 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, youll support your journey every step of the way.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters 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. Together, we compete in the fight against serious disease.
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.
Senior Director Observational Research employer: Amgen, Inc.
At Amgen, we are dedicated to serving patients and fostering a collaborative, innovative work culture that prioritises personal and professional growth. As a Pharmacovigilance Scientist Manager, you will enjoy the flexibility of working from home or in our vibrant Cambridge or Uxbridge offices, while being part of a diverse community that values your contributions and empowers you to make a meaningful impact in the biotech industry.
