Country Clinical Operations Director
il y a 1 semaine
Overview
The Country Clinical Operations Head is a key leader for Clinical Operations at the French level, responsible for the strategic and operational management of clinical operations and clinical site management activities for the assigned country. This role is accountable for leading the implementation of the corporate vision and objectives, operating across all therapeutics areas to support the execution of AbbVie's pipeline.
Main 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.
- Provides leadership, strategic direction, and oversight for all country activities across all stages of the clinical trial, ensuring high quality and scientific integrity of trial deliverables.
- Leads the clinical research team, including performing accompanied visits, accelerating AbbVie's priority programs through close collaboration with internal and external stakeholders, conducting trend analysis and gap assessments to proactively identify training and developmental opportunities for assigned personnel, driving performance, and addressing gaps to ensure the team achieves country and site-level KPIs, KRIs, and metrics.
- 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.
- Accountable for the identification of resource needs, management of allocated resources, and timely hiring of clinical research staff to support clinical trials execution. Responsible for maintaining team capacity aligned with organizational needs, applying flexible and effective approaches for responsibilities assignment, that promotes staff development and retention.
- Defines and implements the optimal team organizational structure to support the needs of the business, ensuring effective collaboration with key capabilities and roles. Identifies and implements strategies and tactics to ensure continuous efficiency, effectiveness, and productivity of the country. Responsible for building a high-performing team, accountable for the operational excellence in the execution of clinical trials.
- Accountable for ensuring adherence to applicable global and local regulations, ICH Guidelines, and AbbVie Quality Management System, promoting a quality-driven local organization, oriented to continuous improvement and excellence. Accountable for country intelligence and impact analysis of all significant changes affecting the conduct of clinical studies, and for implementing procedural adjustments and orientation to guarantee team preparedness, alignment, and compliance, as needed.
- Ensures Inspection Readiness across all activities, through effective leadership and oversight, promoting quality-driven initiatives. Responsible for the development of a critical thinking organization, focused on gap assessment, risk identification, and mitigation strategies. Acts as the country expert for audit and inspection-related processes, and may also serve as the local AbbVie host for in-country inspections/audits.
- Accountable for functional budget planning and management, ensuring accurate budgets and forecasts. Works closely with finance counterparts, guaranteeing seamless budget control processes and accurate communication of budget status, cost, and issues to allow timely decision-making. Responsible for country feasibility, site selection strategy, and expanding AbbVie's site footprint within the country to support the pipeline.
Qualifications
- Bachelor's or equivalent degree, health-related (e.g., Medical, Scientific, Nursing, Pharmacy) preferred.
- Minimum of 5 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 fully 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 2 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.
- 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 approaches stakeholders with customer service orientation in order to be perceived as a clinical study partner of choice.
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