Country Clinical Operations Head

2 weeks ago


Chicago, United States Council of State and Territorial Epidemiologists 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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Spain Clinical Operations Head is the key leader for Clinical Operations at the country level for both internal and external partners. Accountable for the strategic and operational management for clinical operations and clinical site management activities for the assigned country/ies. Responsible for leading the implementation of the corporate vision and objectives, operating across all therapeutics areas to support the execution of AbbVie's pipeline. The role is accountable for country clinical trial performance, providing strategic planning, oversight and direction of the country team to ensure on time, within budget and quality delivery of internally conducted clinical studies. The Country Clinical Operations Head is accountable to develop a highly collaborative framework with internal and external key stakeholders across the local and global organization to best position AbbVie in advancing clinical research and accelerating the transformation of science into first‑in‑class and best‑in‑class medicines. Responsibilities Defines the country strategy and operational plans aligned with AbbVie's business priorities, Clinical Development Operations and affiliate objectives to position the country for near‑ and long‑term success. Continuously assesses country site footprint across all therapeutic areas, expanding where there are opportunities and needs to support the pipeline. Provides leadership, strategic direction and oversight for all country activities across all stages of the clinical trial (country & site feasibility, selection and start‑up, throughout study conduct and closure), ensuring high quality and scientific integrity of trial deliverables. Accountable for all Country level CDO deliverables for internally managed Clinical Studies. Provide leadership and oversight to the clinical research team including, but not limited to: • performing accompanied visits (on‑site and off‑site) • accelerate AbbVie's priority programs through close collaboration with internal and external stakeholders • conduct trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel • drive performance and address gaps to ensure the team achieves country and site level KPIs, KRIs and metrics. • lead the team in expanding country footprint through territory development and outreach to new sites, execution of clinical programs in new disease areas, and driving patient diversity and inclusion in our clinical trials. Partners with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through the contribution to the R&D portfolio success. Partners with GMA Medical Affairs Head to co‑Lead the "One R&D" collaboration within the affiliate. Operates as "CDO Head" to support and represent non‑CSM CDO personnel based Qualifications Education: Bachelor's degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy). Minimum of 10 years of work experience in clinical research, demonstrating a high level of expertise on study monitoring and management across multiple Therapeutic Areas, Study Phases and in full cycle (startup to closeout) processes. Solid understanding of drug development process (and medical device preferred) and requirements such as GCP, ICH, etc. Robust knowledge of local clinical trial setting (regulatory and healthcare environment). At least 5 years of experience in line management of staff including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred. Proven track record in project management, strong planning and organizational skills and a high level of adaptability in a dynamic environment with experience leading (within country or region) projects with competing deadlines. Experience in setting and driving the strategy and leading the management and completion of global trials assigned to the country/ies. Experience in functional budget planning (preferred), resource planning & assignment, quality management at country or regional level. Strong leadership competencies. Robust experience in leading teams through change, leveraging team contributions to support business strategies. Give guidance and inspiration to their direct reports and teammates. Fosters an environment that promotes the sharing of ideas, information, and best practices (internal and external to the organization) to drive continuous improvement. Proven leadership skills in a cross‑functional, matrix environment, with ability to influence and align key stakeholders, forge strong partnerships where needed and promote seamless collaboration at all levels. Proactively responds to the needs of others and makes their own needs and business strategy known. Externally, stakeholders with customer service orientation to be perceived as a clinical study partner of choice. Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to communicate persuasively in a succinct and comprehensive manner to colleagues at all levels. Engenders trust throughout the organization and seek to grow and stretch key talent for future possibilities. Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Additional Information 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. US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html #J-18808-Ljbffr



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