Director, Centralized Study Support (CSS)
Location: Hyderabad, India
Work Type: On-Site
Department: Clinical Development
Position Summary
The Director, Centralized Study Support (CSS) is responsible for building, leading, and scaling a large centralized study support organization that enables efficient clinical trial execution across global portfolios. This leadership role provides strategic direction, operational oversight, workforce planning, and capability development to ensure consistent delivery, quality, and organizational excellence.
The Director oversees resource allocation, capacity planning, leadership development, stakeholder engagement, quality compliance, and operational transformation while fostering a high-performing, inclusive, and scalable organization aligned with evolving business and portfolio needs.
Key Responsibilities
Global CSS Leadership
Provide strategic and operational leadership to a large, multi-layered Centralized Study Support organization.
Lead senior managers and managers to ensure consistent delivery, operational excellence, and employee engagement.
Establish and communicate the long-term vision, priorities, and operating model for the CSS function.
Align CSS strategy with Global Development Operations objectives and portfolio requirements.
Define governance structures, accountability frameworks, and decision-making processes.
Drive consistency and excellence across teams, programs, and geographies.
Organizational Strategy & Execution
Develop and execute functional strategies that support clinical development and study delivery objectives.
Monitor operational performance through:
Key Performance Indicators (KPIs)
Capacity Metrics
Resource Utilization Metrics
Quality Indicators
Identify risks, operational gaps, and opportunities for improvement.
Drive execution against organizational goals and strategic initiatives.
Leadership Development & Talent Management
Lead, coach, and mentor senior leaders across the CSS organization.
Build leadership capability, succession readiness, and organizational resilience.
Guide leaders through:
Performance Management
Workforce Planning
Organizational Design
Talent Development
Change Management
Foster a leadership culture centered on accountability, collaboration, and continuous learning.
Promote leadership excellence across global teams.
Culture, Engagement & Performance Excellence
Build and sustain a culture of:
Accountability
Inclusion
Collaboration
Delivery Excellence
Continuous Improvement
Create an environment where diverse perspectives are valued and employee engagement is prioritized.
Promote employee development, retention, and career growth.
Recognize high performance while addressing capability and performance gaps.
Ensure employees understand organizational goals and expectations.
Resource Strategy & Workforce Planning
Provide strategic oversight of workforce planning and resource management across clinical programs.
Lead:
Capacity Forecasting
Demand Planning
Resource Allocation
Workforce Optimization
Ensure resource deployment aligns with portfolio priorities and business objectives.
Anticipate supply-demand challenges and implement proactive mitigation strategies.
Support hiring strategies and long-term workforce planning initiatives.
Resource Allocation Governance
Establish governance frameworks for resource allocation decisions.
Lead scenario planning and capacity management discussions.
Evaluate allocation trade-offs across:
Studies
Programs
Therapeutic Areas
Global Regions
Optimize utilization of internal and external resources.
Functional Service Provider (FSP) Oversight
Provide oversight of Functional Service Provider (FSP) partnerships supporting CSS activities.
Monitor vendor performance, capacity, and service quality.
Ensure external resources align with organizational requirements and business objectives.
Drive accountability and continuous improvement across vendor relationships.
Stakeholder Partnership & Governance
Build strong partnerships with senior stakeholders across Global Development Operations and related functions.
Serve as the senior escalation point for operational, resourcing, and delivery-related issues.
Communicate:
Strategic Updates
Portfolio Insights
Resource Risks
Operational Recommendations
Support executive-level decision-making through data-driven insights and analysis.
Quality, Compliance & Risk Management
Ensure organizational compliance with:
Standard Operating Procedures (SOPs)
Regulatory Requirements
Quality Standards
Internal Controls
Identify and mitigate operational, compliance, and resourcing risks.
Support audit and inspection readiness across the CSS organization.
Promote a culture of quality and accountability.
Operational Excellence & Continuous Improvement
Identify organizational capability gaps and develop strategies to strengthen expertise and scalability.
Lead process optimization and transformation initiatives.
Improve:
Processes
Systems
Tools
Reporting Frameworks
Governance Models
Drive operational efficiency, transparency, and consistency.
Promote innovation, automation, and adoption of emerging technologies, including AI-driven solutions where appropriate.
Enterprise Planning Support
Partner with Global Development Operations and cross-functional stakeholders on:
Workforce Planning
Hiring Strategies
Capacity Forecasting
Portfolio Planning
Organizational Growth Initiatives
Support enterprise-wide resource planning and strategic workforce decisions.
Basic Qualifications
Candidates must meet one of the following requirements:
Doctorate Degree, OR
Master's Degree, OR
Bachelor's Degree with 18+ years of relevant professional experience.
Additional Leadership Requirement
Minimum 5 years of direct people management and/or leadership experience.
Demonstrated experience leading:
Teams
Programs
Organizational Change Initiatives
Resource Allocation Decisions
Experience managing:
Capacity Forecasting
Demand Prioritization
Resource Trade-Off Decisions
Global Portfolio Resource Planning
Preferred Qualifications
10+ years of experience in life sciences, biotechnology, pharmaceutical, healthcare, or related industries.
Significant biopharmaceutical clinical research experience within:
Biotechnology Companies
Pharmaceutical Organizations
Contract Research Organizations (CROs)
Experience building and scaling teams from inception.
Proven success creating high-performing and inclusive organizations.
Experience overseeing complex resource management across global clinical portfolios.
Demonstrated success leading organizational transformation and continuous improvement initiatives.
Experience supporting large-scale global clinical development operations.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Berlin |Baden-Wurttemberg :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
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Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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