Director II, R&D Digital & Data Strategy

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.

About the Role:

At AbbVie our mission is to discover and deliver innovative medicines that make a remarkable impact on people’s lives.  The AbbVie Convergence initiative within our Research & Development organization represents an unparalleled effort to integrate, harmonize and democratize data that will drive the future of medicine and improve the experience and quality of care for patients around the globe.  It represents a fundamental transformation of how medical data and knowledge is generated, shared, and utilized both inside and outside of AbbVie.  The ARCH or AbbVie’s Research Convergence Hub, will bring together clinical, real-world, operational, genomic, safety and public and licensed data and drive correlations and insights that will lead to new therapies and new ways of enhancing patient and care provider’s lives.  Our R&D scientists, data scientists, statisticians and clinicians will work together as part of Convergence to leverage the ARCH along with advanced data analytics to fuel key scientific and clinical decisions.

The Director, Regulatory Affairs Data Integration, is an experienced regulatory affairs professional who understands drug development, approval, and launch. We expect this person to bring that experience to the Convergence team and to Global Regulatory Product Teams (GRPT) by identifying data sources both internally and externally that we could use differently as we develop our products. The Catalyst will prospectively meet with GRPTs to identify product needs and develop use cases that will increase the success of our product launches.

We are looking for an experienced Director, Regulatory Affairs Data Integration to be a change agent  who leads RA and R&D to adopt Convergence principles.  The Director will help define Regulatory Affairs Convergence strategies to advance functional priorities while maintaining alignment with the overarching R&D Convergence framework and priorities.  She or he will be an active member of the R&D Convergence Core team responsible for defining and executing the R&D Convergence strategy and will represent Regulatory Affairs in cross-functional discussions related to Convergence.

The Director, Regulatory Affairs Data Integration will partner with GRPTs within Regulatory Affairs and across R&D to identify and lead projects involving the aggregation and analysis of diverse data sets to identify key trends and insights that contribute to successful product development and launch.  She or he will ensure that these projects have a substantial return on investment and a measurable effect on the AbbVie pipeline of new medicines and R&D priorities.

 

Responsibilities:

• Influence Regulatory Affairs leadership, strategies and investments to align with the R&D Convergence vision
• Translate Regulatory Affairs business challenges and scientific questions into analytics hypotheses that can be tested using data analytics to develop and launch new products
• Be an active member of the R&D Convergence Core team and represent Regulatory Affairs in critical meetings and decision-making forums
• Partner with the R&D Convergence ‘SWAT Team’ (R&D Computational Center of Excellence) and the ARCH (AbbVie’s Research Convergence Hub) team to advance complex or highly novel use-cases with cross-functional dependencies
• Identify opportunities and solutions to unleash the full value of Convergence within Regulatory Affairs at an accelerated pace
• Lead Convergence projects within Regulatory Affairs
• Act as a conduit between the R&D Convergence Core Team and the GRPTs to transfer innovation, knowledge, best practices and lessons learned
• Be an active member of the community of R&D Convergence Directors across other R&D functions and enable cross-pollination of ideas for broader R&D implementation
• Act as a consultant within Regulatory Affairs to help identify where Convergence and analytics approaches can help answer questions
• Influence the Regulatory Affairs talent strategy to enhance the digital skills and acumen of scientists and leaders to align with the Convergence vision

Qualifications

Minimum Qualifications:

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• 10-15  years industry related experience
• Proven 7-10 years in a leadership role with strong management skills

 

• In-depth understanding of the core business areas within Regulatory Affairs
• Proven experience leading and navigating in a matrixed organization

 

Preferred Qualifications:

• Relevant advanced degree preferred (MS, PhD, Law)
• 5-7 years in regulatory affairs
• 10+ years pharmaceutical experience (medical device/combination product)
• Broad understanding of the R&D drug discovery and development process
• Robust understanding of the data analytics value chain from data to decision
• Proven experience with successfully enabling new digital or data science capabilities that are beyond incremental extensions of the current capabilities
• Proven track record of continuous learning and ability to apply the learning to enable new value propositions
   

 

Key Stakeholders:

Data Integration Directors from other R&D functions (cross-functional peer group); Convergence Core Team including Senior Director, Data Integration and R&D Data Governance Leaders; R&D Convergence Steering Team including VPs and senior leaders from each R&D function, legal, safety and HEOR; will lead matrixed teams including scientists, data scientists and MDs at all levels of the technical and medical career ladders; Regulatory Affairs GRPTs and leadership.

 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
D
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.