Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference

Career Category

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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.

Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead a Pharmacovigilance Epidemiology and Causal Inference team within the Data and Analytics Center (DAC). A CfOR director is recognized as a strong scientific contributor and is a first or contributing author for papers in peer-reviewed journals or for internal reports that enhance the company’s mission. This role will primarily be located on the Amgen corporate campus in Thousand Oaks, CA, but remote opportunities may also be available.

The team consists of 6+ epidemiologists and works collaboratively across therapeutic areas to design and implement studies using real-world data to inform questions related to product safety and effectiveness. Responsibilities range from estimating exposure to Amgen medicines across countries, estimating background rates of events to inform signal evaluations, conducting post-approval safety studies globally (including post-marketing requirements, commitments, and post-authorization safety studies) to evaluate the benefit-risk balance of Amgen therapies, and conducting studies requiring advanced causal inference methodologies including real-world comparative effectiveness. The team is also responsible for developing and optimizing analytic tools to enable the delivery of high-quality, principled, and state of the art research efficiently for the organization. In addition to managing and coordinating this work, the Director will also serve on the Extended Leadership Team (ELT) of the department and actively engage in efforts around department strategy, prioritization, and talent and culture. Additionally, the Director will work cross-functionally with Global Patient Safety and Global Regulatory Affairs and Strategy at the leadership level to optimize the use of real-world evidence to inform patient benefit-risk and regulatory decision making.

• Effectively leads, develops, and mentors a team of scientists
• Design and execute studies to support evidence generation such as identifying appropriate patient populations, assessing disease burden and resource utilization, obtaining product registrations and label-expansions, meeting post-marketing requirements/commitments, and product differentiation
• Find opportunities to substitute for and/or complement interventional studies to reduce time and cost of drug development
• Influence cross-functional team members as to the appropriate use and timing of non-interventional research to answer high-priority strategic business questions
• Leverage real-world data and CfOR analytic approaches to inform high-value business decisions for multiple stakeholders
• Track business and functional priorities and align resources against those priorities
• Contribute to the mission of CfOR, including progressing innovative epidemiological methods and analytical capabilities to support CfOR’s leadership role within Amgen and industry
• Participate in initiatives to improve capabilities within CfOR and provide input into CfOR meetings
• Contribute to the development of product and CfOR strategies
• Develop and maintain relationships with key leaders in observational research

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of scientific experience

OR

Master’s degree and 8 years of scientific experience

OR

Bachelor’s degree and 10 years of scientific experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing peo