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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

Purpose:

AbbVie’s Digital Science Team is a novel capability team with a unique blend of medical, clinical technology, regulatory and data science expertise. The team leads the development and validation of digital health solutions to objectively measure aspects of diseases, detect treatment benefits, unlock new value for our portfolio, and drive the future of the business. As a part of AbbVie’s Digital Science Team, you will have the opportunity to shape the future of medicine development with Digital Health solutions. The Digital Health Strategist serves a key strategic leadership role in the asset strategy teams. You will be responsible to define digital strategy, drive the development and validation of digital measurements, lead the evidence generation, and bring digital strategies to life in meaningful ways for AbbVie and patients. You will also represent AbbVie externally and contribute to industry trade organizations and consortia collaboration to foster the adoption of digital solutions.

Responsibilities:

• Identify Neuroscience asset strategy needs and define digital strategy accordingly. Collaborate with cross-functional asset teams and Therapeutic Areas to implement digital strategies, align to asset strategy and generate high-quality evidence suitable to support decision making, label enhancement, or market access.

• Lead indication-wide Digital Strategy for evidence generation and serve as key strategic partner across asset strategy teams within a given indication in the Neuroscience Therapeutic Area.

• Lead analytical validation studies of digital tools, adhere to PFDD, DDTQ, CTTI guidance as well as other relevant federal and international regulations, including GCP, ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stay abreast of new and evolving regulations, guidelines and policies related to digital health and clinical development

• Establish external presence and thought leadership in the field of human neuroscience, digital medicine, algorithm development and clinical decision support tool validation with peer-reviewed journal publications and presentations at global congresses.

• Help influence external stakeholders such as regulatory agencies, HTAs, advocacy groups, consortia, industry trade organizations, and investigators.

• Manage multiple digital projects with people and project management skills, e.g. create project plans, value/KPI trackers, monitor scope, budget, timeline, and report milestones/progress.

• Author digital strategy plans, digital data analysis plans, sections of CSR, technical reports, and support publications and presentations.

• Provide SME input on the sections of documentation for regulatory agency meetings. Participate in said meetings to address technical questions raised by regulatory agencies.

• Responsible for mentoring and coaching junior and/or supporting matrix team members and ensure the proper methodologies and scientific rigor are applied to deliver high-quality results.

• Identify business needs and develop guidance, SOPs, and good practice documents. Support/create training, workshops and educational webinars to help establish a knowledge base of digital health and digital endpoint development and strategy within AbbVie.

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• BS required. Graduate training preferred (PhD with 6+ years, MS with 8+ years, and BS with 10+ years).

• Training in neuroscience, behavioral science, cognitive science, or similar with extensive human subjects research experience

• Deep understanding of contemporary neuroscience measurement approaches and their application to understanding human health and disease

• Basic understanding of signal processing, time-series, or image analysis methods, and associated statistics

• Solid understanding of the drug development process, with demonstrated experience in seeing projects and assets progress through the pipeline

• An understanding of the regulatory requirements for new digital endpoints, critical success factors and obstacles impacting device driven outcomes in successful regulatory label negotiations

• Trusted team leader with people and navigation skills

• Strong ability to collaborate with cross functional matrix teams and external experts to influence strategies

• Expert communication and presentation skills

• Ability to influence key stakeholders such as leadership teams, regulatory agencies, HTA bodies and investigators

• Excellent understanding of changing pharmaceutical, regulatory, and technology environment

• Methodical, detail-oriented, critical thinker with value-evidence mindset and problem-solving skills, the ability to manage people and projects as well as collaborate and influence cross-functionally in a highly matrixed environment is desired

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​​

• This job is eligible to participate in our long-term incentive programs. ​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.