Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Director of Observational Research, Pharmacovigilance Epidemiology and Causal Inference

Do you want an exciting position working with multiple teams to generate real-world evidence supporting a wide variety of business needs?

The growing demand for real-world evidence (RWE) from regulatory and reimbursement authorities makes Observational Research a key component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with an industry-leading analytical capability that generates RWE to support business needs across a products lifecycle. CfOR scientists partner with internal collaborators and industry experts to craft, conduct, interpret, and publish Observational Research that advises decision-making from the early development of a molecule to the design of clinical trials and the safety and efficacy of Amgen medicines. CfOR studies include but are not limited to evidence generation regarding the frequency and distribution of disease, the clinical burden of disease, the natural history or clinical course of the disease, the design of clinical trials, treatment cost, and utilization patterns, and the safety and efficiency of therapeutic interventions.

What you will do

Lets do this. Lets 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 companys mission. This role will primarily be located on the Amgen corporate campus in Thousand Oaks, CA, but remote opportunities may also be available.

The Pharmacovigilance Epidemiology and Causal Inference 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 overseeing 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 CfORs 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. We are looking for a Director with these qualifications:

Doctorate degree and 4 years of scientific experience

OR

Masters degree and 8 years of scientific experience

OR

Bachelors degree and 10 years of scientific experience

In addition to meeting at least one of the above requirements, you must have a minimum of 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above

• Doctorate in Epidemiology or other subject with high Observational Research content
• Experience in the design, execution, and analysis of Observational Research studies within Pharmaceutical or Public Health setting
• Experience in research to support drug development
• Experience in Observational Research project planning and management
• Excellent verbal and writing communication and interpersonal skills
• Experience working in multi-disciplinary teams

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.