Observational Research Manager - Pharmacovigilance Epidemiology and Causal Inference

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 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 awardwinning 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.

Observational Research Manager

What you will do

Lets do this. Lets change the world. In this vital role you will have responsibilities related to comparative research and regulatory safety studies executed by the Safety and Pharmacoepidemiology team in the Data and Analytics Center (DAC).

Observational research (OR) makes important contributions to drug development commercialization and safety evaluation. OR gives evidence regarding the frequency and distribution of disease the natural history and clinical burden of disease the design of clinical trials cost and utilization patterns and the safety and efficacy of therapies. There is growing demand for information from ORbased evidence by regulatory and reimbursement authorities. The Center for Observational Research (CfOR) was built to address this imperative.

The CfOR Manager 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 address the companys mission.

This position will be remote.

Key Activities include but are not limited to:

• Designs and implements models to estimate patient exposure to Amgen marketed products.
• Designs and implements retrospective database studies in support of safety and pharmacovigilance.
• Provides epidemiological input to worldwide regulatory submissions such as PSURs and RMPs.
• Executes or leads research projects involving the analysis of multiple databases
• Provides safety research support across the life cycle of Amgen products
• Supports development of risk management plans
• Conducts literature reviews and prepares research reports and scientific manuscripts
• Stays abreast of the latest developments in the field of observational research and drug development
• Promotes awareness understanding and use of observational research methods
• Supports relationships with key leaders in observational research
• Provides input into observational research department meetings
• Communicates significant scientific information to a variety of audiences

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.

Basic Qualifications:

Doctorate degree

Or

Masters degree and 2 years of scientific experience

Or

Bachelors Degree and 4 years of scientific experience

Or

Associates degree and 8 years of scientific experience

Or

High school diploma / GED & 10 years of scientific experience

Preferred Qualifications:

• Doctorate in Epidemiology or other subject with high observational research content
• Experience in the design execution and analysis of observational research studies within a pharmaceutical or public health setting
• Experience in observational research project planning and management
• Experience communicating observational research information written and oral
• Experience working in multidisciplinary teams
• Record of publications in observational research or clinical journals

What you can expect from us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and wellbeing. From our competitive benefits to our collaborative culture well 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.

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 salesbased incentive plan
• Stockbased longterm incentives
• Awardwinning timeoff plans
• Flexible work models including remote and hybrid work arrangements where possible

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove ageidentifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen 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.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse 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 and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

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. 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.

Salary Range