Director, Country Clinical Operations Management

By Admin ยท Clinical Research & Clinical Operations

BANGALORE (IN)HYBRIDPOSTED: 9/5/2026
PHARMAFull-time
HIRING ORGANIZATIONABBVIEBiopharmaceuticals / Life Sciences
AbbVie

ROLE DEFINITION & RESPONSIBILITIES

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

Full-time position.
Hybrid work location.
Primary location: Bengaluru, Karnataka, India.

REQUIRED VERIFIED SKILLS

Clinical Operations
Clinical Trial Management
Country Clinical Operations
Clinical Site Management
Clinical Research
Strategic Planning
Clinical Study Execution
Site Feasibility
Site Selection
Study Start-Up
Study Conduct
Study Closure
ICH Guidelines
Global Regulations
Local Regulations
Quality Management System
Inspection Readiness
Audit Management
Risk Identification
Risk Mitigation
KPI Management
KRI Management
Budget Planning
Forecasting
Resource Management
Workforce Planning
Team Leadership
Clinical Development Operations

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
The supplied job description does not disclose an official salary range, bonus amount, equity details, or specific benefits package, so salary_min and salary_max are left blank. Compensation for a Director-level Clinical Operations position would depend on leadership scope, clinical-development experience, country responsibilities, organizational level, location, and total-rewards structure. No unofficial salary estimate is presented as employer-confirmed information.

ORGANIZATION CONTEXT & CULTURE

AbbVie is actively hiring for this position.

INDUSTRY: Biopharmaceuticals / Life Sciences

EXPECTED CAREER ROADMAP

This Director-level role provides a senior leadership pathway within global Clinical Development Operations and Research & Development. Strong performance can lead toward Senior Director, Executive Director, or broader regional/global Clinical Operations leadership. The role also develops capabilities relevant to country or regional CDO leadership, global clinical-development strategy, portfolio and program management, operational excellence, clinical quality, inspection readiness, and affiliate R&D leadership. Its combination of people leadership, strategic planning, clinical-trial execution, resource management, financial accountability, regulatory compliance, and executive stakeholder engagement provides broad preparation for senior global clinical-development leadership.

APPLICATION ADVISORY

For applications, emphasize senior leadership experience in country or regional clinical operations and demonstrate ownership of clinical-trial delivery rather than only individual study execution. Highlight responsibility across feasibility, site selection, start-up, conduct, and close-out. Clearly demonstrate people leadership, workforce planning, hiring, performance management, talent development, retention, KPI/KRI ownership, and operational excellence. Include experience with ICH Guidelines, global/local regulations, Quality Management Systems, audits, inspections, risk management, and inspection readiness. Quantify team size, number of studies/sites supported, therapeutic areas, countries, budgets, recruitment timelines, delivery improvements, quality outcomes, and risk-mitigation results. Prepare leadership examples involving country strategy, difficult stakeholder decisions, resource constraints, underperforming teams, inspection readiness, clinical-study risks, budget management, site-footprint expansion, and collaboration with Medical Affairs/R&D. Be prepared to discuss how you would align local clinical operations with a global pipeline and build a high-performing matrix organization.
RECOMMENDED TRAINING
1/5

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