Director, Clinical Management, Device & Combination Product Development

Company Description

About Abb Vie

Abb Vie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

The Abb Vie R&D Device and Combination Product Development (DCPD) function provides device development expertise for Aesthetic Devices and Therapeutic Combination Products. Within this space, DCPD is accountable for enabling Abb Vie's R&D pipeline by supporting clinical cross-functional partners and ensuring the successful integration of devices and drug delivery systems throughout development.

We are seeking a Director, Clinical Management within the DCPD organization to provide strategic and operational leadership for clinical activities involving devices and combination products across Abb Vie's global portfolio. The Director is accountable for defining the strategy, setting organizational direction, and ensuring effective execution of device and drug delivery system readiness activities across clinical development programs.

As the functional leader for DCPD Clinical Management, the Director will lead and develop a global organization, establish scalable processes and standards, and drive alignment across Clinical Development, Clinical Operations, Clinical Supply, Regulatory Affairs, Quality, Human Factors, Systems Engineering, and Device Development teams. The Director will influence clinical readiness while ensuring the organization is positioned to support current and future pipeline needs.

Responsibilities

• Define and execute the global strategy and operating model for DCPD Clinical Management in alignment with Abb Vie R&D portfolio priorities and long-term business objectives.
• Represent device and combination product development in cross-functional and governance forums, providing strategic input and influencing clinical development strategies, portfolio priorities, and organizational decision-making.
• Lead, develop, mentor, and coach a global organization, including leadership capability, succession planning, talent development, and a culture of accountability, collaboration, innovation, and continuous learning.
• Provide strategic oversight for device and drug delivery system readiness activities across global clinical trials, from study initiation through completion, including coordination with clinical supply, study preparation, complaint handling, and regulatory submissions.
• Drive strategic planning, resource allocation, and prioritization across multiple development programs and therapeutic areas, ensuring effective deployment of organizational resources.
• Champion organizational continuity and continuous improvement — identifying opportunities to enhance processes, and ways of working across the function.
• Partner with Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Human Factors, Systems Engineering, Device Development, and Clinical Supply to align strategies, resolve complex issues, and mitigate clinical, technical, operational, and regulatory risks.
• Provide strategic oversight and review of clinical study protocols, reports, administration instructions, training materials, and device-related regulatory submission content to ensure alignment with device and delivery system requirements.

• Bachelor’s Degree or equivalent education in Science related field with extensive (typically 18 years) of related work;
  Master’s…