Role Overview
The Director, Country Clinical Operations Management is the key clinical-operations leader at country level for internal and external partners. The role has strategic and operational accountability for clinical operations and clinical site-management activities within the assigned country or countries. The Director leads implementation of AbbVie's clinical-development vision and objectives across therapeutic areas and is accountable for country clinical-trial performance, strategic planning, operational oversight, quality, budget, resources, and delivery of internally managed clinical studies.
Country Clinical Operations Strategy
Define country strategy and operational plans aligned with AbbVie's business priorities, Clinical Development Operations objectives, and affiliate objectives.
Position the country for near-term and long-term clinical-development success.
Continuously assess the country's clinical-site footprint across therapeutic areas.
Expand the site footprint where opportunities and pipeline requirements justify additional sites.
Develop country and site-selection strategies to support the clinical pipeline.
Provide strategic direction across the complete clinical-trial lifecycle, from feasibility and site selection through start-up, study conduct, and closure.
Clinical Trial Leadership & Operational Oversight
Provide leadership, strategic direction, and oversight for country clinical-operations activities across all stages of clinical trials.
Ensure high-quality and scientifically sound trial deliverables.
Maintain accountability for country-level Clinical Development Operations deliverables for internally managed clinical studies.
Ensure clinical studies are delivered on time, within budget, and to required quality standards.
Accelerate priority AbbVie programs through close collaboration with internal and external stakeholders.
Provide oversight of clinical research and site-management activities across therapeutic areas.
Clinical Research Team Leadership
Provide leadership and oversight to the clinical research team.
Conduct accompanied visits, including on-site and off-site visits, where required.
Conduct trend analysis and gap assessments to proactively identify personnel training and development needs.
Drive performance improvement and address capability or execution gaps.
Ensure achievement of country- and site-level KPIs, KRIs, and operational metrics.
Build a highly collaborative, high-performing clinical research organization.
Promote staff development, retention, effectiveness, and operational excellence.
R&D & Stakeholder Collaboration
Partner with internal stakeholders to create insightful and impactful interactions.
Promote the value and contribution of the clinical research team to overall R&D portfolio success.
Partner with the GMA Medical Affairs Head to co-lead One R&D collaboration within the affiliate.
Operate as the CDO Head to support and represent non-CSM Clinical Development Operations personnel based within the affiliate.
Establish effective relationships across local and global organizations and with external partners.
Work in a matrix and evolving organizational environment requiring broad stakeholder influence and collaboration.
Resource & Workforce Management
Identify country clinical-research resource requirements.
Manage allocated resources according to clinical-trial and organizational needs.
Ensure timely hiring of clinical-research personnel to support trial execution.
Maintain team capacity aligned with organizational requirements.
Apply flexible and effective approaches to responsibility assignment.
Structure assignments in ways that support employee development and retention.
Define and implement the optimal team organizational structure for business needs.
Organizational Effectiveness & Operational Excellence
Build and maintain a high-performing country clinical-operations team.
Develop organizational structures that enable effective matrix collaboration.
Identify and implement strategies to improve country efficiency, effectiveness, and productivity.
Drive operational excellence in clinical-trial execution.
Promote continuous improvement and a quality-driven culture.
Ensure the country organization remains prepared to adapt to changing business, scientific, and regulatory requirements.
Quality, Compliance & Regulatory Oversight
Ensure adherence to applicable global and local regulations.
Ensure compliance with ICH Guidelines and AbbVie Quality Management System requirements.
Promote a quality-driven local organization focused on continuous improvement and excellence.
Monitor significant regulatory, procedural, and operational changes affecting clinical-study conduct.
Lead country intelligence and impact analysis for significant changes.
Implement procedural adjustments and provide appropriate orientation to ensure team preparedness, alignment, and compliance.
Inspection Readiness & Risk Management
Ensure inspection readiness across country clinical-operations activities through effective leadership and oversight.
Promote quality-driven inspection-readiness initiatives.
Develop a critical-thinking organization focused on proactive gap assessment.
Drive identification, assessment, and mitigation of clinical-trial risks.
Develop and implement appropriate risk-mitigation strategies.
Serve as the country expert for audit and inspection-related processes.
May act as the local AbbVie host during in-country regulatory inspections and audits.
Financial & Budget Management
Own functional budget planning and management for the country clinical-operations organization.
Ensure accurate budgets and financial forecasts.
Work closely with Finance counterparts on budget-control processes.
Maintain accurate communication regarding budget status, costs, and financial issues.
Enable timely financial decision-making through effective forecasting and budget oversight.
Ensure country feasibility and site-selection strategies are appropriately aligned with pipeline and resource requirements.
Business & Pipeline Impact
Position country clinical operations to support AbbVie's development pipeline across therapeutic areas.
Expand clinical-site capabilities and footprint where required to support future studies.
Ensure high-quality, scientifically robust, compliant clinical-study execution.
Balance resources, operational efficiency, quality, risk, timelines, and financial requirements.
Strengthen collaboration between local affiliate teams, global Clinical Development Operations, Medical Affairs, and external partners.
Work Pattern
Primary location: Bengaluru, Karnataka, India.