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Associate Director, Digital Science- Oncology

4 months ago

North Chicago, United States AbbVie, Inc Full time

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

AbbVie's Digital Science Team is a novel capability team bridging medical, scientific, technology, regulatory, and data science expertise to deploy digital health technologies (DHTs) into our studies. We focus on overarching strategy based on evidence gaps; search and evaluation of technologies to address these gaps; study design and DHT operationalization; and analysis of the complex data captured using DHTs. As a part of AbbVie's Digital Science Team, you will have the opportunity to shape the future of how we develop medicines and make them accessible to patients.

This role as a Digital Health Strategist serves a key leadership function to understand and interpret evidence gaps and address them with DHTs. You will be responsible for defining digital strategy, driving the development and validation of digital measurements, and leading evidence/insight generation in collaboration with study teams and Digital Science data scientists. You will also represent AbbVie externally through scientific communications and contribute to industry trade organizations and consortia to foster the adoption of digital solutions.

Responsibilities:

* Identify Oncology asset strategy needs and define digital strategy accordingly. Collaborate with cross-functional teams within AbbVie 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 Oncology 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 Oncology, 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, technical reports, and support publications and presentations.


* Provide subject matter expertise 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 (MD or PhD with 6+ years, MS with 8+ years, or BS with 10+ years)


* Training or relevant experience in oncology, cancer biology, or similar with extensive human subjects research experience


* Expert communication and presentation skills with demonstrated track record of scientific communication


* Trusted team leader with people and team navigation skills


* Deep understanding of contemporary digital measurement approaches and their application to understanding human health and disease


* Functional understanding of signal processing, time-series, 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


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


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


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



Additional Information

Applicable only to applicants