Associate Director, Clinical Management, Device & Combination Product Development

About the role

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 to enable AbbVie's Early R&D Pipeline by providing support to AbbVie's clinical cross-functional partners to ensure the successful inclusion of devices and drug delivery systems throughout the entire process.

Responsibilities

• Represent device and combination product development in cross-functional forums, serving as leader across other stakeholders within the clinical development process.
• Lead, develop, mentor, and coach global team, fostering a culture of accountability, collaboration, and learning while proactively sharing knowledge and insights to build functional capability within DCPD.
• Champion organizational continuity and continuous improvement, identifying opportunities to enhance processes and ways of working across the function.
• Ensure effective assignment and distribution of project responsibilities in alignment with organizational priorities.
• Provide oversight for device and drug delivery system readiness activities across global clinical trials, from study initiation through completion including coordination with clinical supply, clinical study preparation, complaint handling, and regulatory submissions.
• Guide collaboration with human factors, systems engineering, and broader device development teams to design and execute clinical design validation plans within the design controls process.
• Support the team with development of administration instructions and training materials used for clinical trials in collaboration with other cross-functional teams, including clinical development, clinical operations, and human factors.
• Support reviewing clinical study protocols and reports to ensure alignment across devices and delivery system requirements.
• Provide strategic direction and review for device sections of early-stage regulatory submission documents.

Qualifications

• Bachelor's Degree in Science related field with 16 years of related work; Masters Degree Science or PharmD with 14 years of related work; or PhD in Science or related field with 8 years of related work experience.
• Strong interpersonal and communication skills with the ability to build relationships with diverse internal and external stakeholders across functions.
• Demonstrated ability to influence and align cross-functional stakeholders and colleagues across multiple areas of expertise.
• Strong track record of people leadership within healthcare, medical device, or pharmaceutical organizations; clinical development experience preferred.
• Exceptional problem-solving skills with the ability to navigate scientific and organizational challenges.
• Techically proficient with an understanding of the medical device and/or pharmaceutical industry; experience with design control processes preferred.
• 10% Travel may be required to coordinate between AbbVie sites, third-party suppliers, and/or clinical sites.