Director Epidemiology-Devices

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Director Epidemiology, Devices is an experienced scientist with primary responsibility to lead observational research for devices. This individual will work withothers in the organization to ensure oversight of strategic epidemiology plans for device products and serve as the primary internal consultant for device epidemiology. The Director may also represent the team to address epidemiology issues to externally, including but not limited to regulatory authorities.

Responsibilities:

• Lead and develop strategies for device product epidemiologic support globally via observational research and collaboration with other functions for study coordination, execution and dissemination of results.
• Provide strategic input with cross-functional team into regulatory interactions, forexample notified bodies and health authorities globally. These may include PMCF,device safety and surveillance, risk evaluation and mitigation strategies, development of strategic plans and submissions.
• Support product development, launches, surveillance and other related activities
• Oversee development of study protocols, database and other analyses, study reports and dissemination research findings.
• Oversee observational studies to describe and quantify disease epidemiology and realworld usage, patient exposure, safety and effectiveness of devices.
• Provide subject matter expertise, guidance and direction to internal and external stakeholders.
• Ensure optimal management of cross-functional projects, identifies potential risks to project objectives, ensure scientific integrity and cost-effective project delivery.
• Participate on advisory committee / device panel meeting preparation teams.
• Develop and maintain excellent relationships with both internal and external stakeholders, qualified vendors/consultants.
• Build partnerships with registries, academic partners, and other external entities toadvance research initiatives.
• Maintain up-to-date knowledge of industry best practices in epidemiology and risk management, recognized as internal expert.
• Maintain keen awareness of regulatory requirements globally, initiatives and advances in device epidemiology especially for the US and EU regions.
• Oversee critical appraisal and synthesis of relevant epidemiologic literature
• Manage direct report(s)
• Other activities as business needs dictate

Qualifications

Basic:

• PhD or equivalent in epidemiology or related degree with relevant experience as an epidemiologist
• At least 5 years' experience in a pharmaceutical company or a CRO with robust device experience including leading FDA mandated long-term studies
• Demonstrated excellent methodological and analytic skills is a must
• Excellent communication, presentation and interpersonal skills
• Ability to adjust to changing priorities
• Navigate and work successfully within a matrix environment

Preferred location:

• Flexibility for remote work will be considered for the right candidate, with travel to AbbVie locations, primarily Irvine, CA as necessary (20-25%).

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Keyboard use (greater or equal to 50% of the workday)
Travel
Yes, 25 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.