Director Clinical Management Device & Combination Product Development

Company Description

About AbbVie

AbbVies 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 peoples lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The AbbVie 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 AbbVies 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 AbbVies 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 AbbVie 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.

Qualifications

• Bachelor's Degree or equivalent education in Science related field with extensive (typically 18 years) of related work; Master's Degree or equivalent education Science or PharmD or equivalent education with extensive (typically 16 years) of related work; PhD in Science or related field with typically 10 years of related work experience.
• Strong track record of people leadership within healthcare, medical device, or pharmaceutical organizations, including experience developing teams and organizational capability; experience with clinical development preferred.
• Demonstrated ability to influence senior and executive leaders and align cross-functional stakeholders across multiple areas of expertise and organizational levels.
• Experience leading complex programs or portfolios, organizational change initiatives, resource prioritization, and continuous improvement efforts within a matrix environment.
• Technically proficient with a strong understanding of the medical device and/or pharmaceutical industry; experience with design control processes preferred.
• Exceptional interpersonal, communication, negotiation, problem-solving, and decision-making skills, with demonstrated ability to navigate complex organizational and business challenges.

Additional Information

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

• 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 long-term incentive programs.

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 Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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