Associate Director Program Data Delivery
Amgen · Hyderabad · onsite · Posted 51d ago
Undisclosed15–20 yrsfulltimeSourced from
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About this role
Role Description:
The Associate Director, Program Data Delivery provides program-level leadership in complex programs and will be accountable for ensuring high-quality, inspection-ready data across studies and programs as needed , driving alignment, consistency, standardization, scalability, and innovation from study planning through database lock.
This role leads and mentors a pod of Data Delivery Leads and Central Monitors ensuring standardized, scalable, and inspection-ready delivery across the portfolio.
The Associate Director serves as the strategic Data Management leader, responsible for shaping delivery models within a therapeutic area, influencing cross-functional decisions, and driving continuous improvement and innovation across programs.
STRATEGIC PILLAR - Define and drive Data Delivery strategy at the program level, aligned to GDO priorities
- Shape and evolve operating models for Program Data Delivery and Central Monitoring, including monitoring of resource needs, governance, and delivery frameworks
- Lead standardization and modernization initiatives (e.g., integrated data review approach, risk-based data management, advanced automation, etc.) across programs
- Influence portfolio prioritization, risk trade-offs, and execution strategies in partnership with Clinical Operations, Biostatistics,Safety, and Medical Monitoring
- Represent Data Management in senior governance forums, providing strategic insights and recommendations
- Build sustainable and scalable capability models (talent, tools, and processes) to support portfolio growth
Portfolio Program Delivery Oversight
- Accountable for end-to-end delivery of high-quality, inspection-ready clinical data across multiple programs, ensuring adherence to timelines, regulatory requirements, and quality standards, while driving consistent database readiness, data cleaning, reconciliation, and seamless database lock execution.
- Drive program-level adoption and cross-study standardization of data management practices - including DMP, IDRP, query management, and reconciliationto improve efficiency, consistency, and scalability across programs
- Manage inter-study dependencies, timelines, and critical paths to ensure seamless program execution and delivery alignment
- Drive adoption of advanced analytics, automation, and AI-enabled data review to enhance data quality, efficiency, and insight generation
- Ensure continuous inspection readiness and proactively support regulatory inspections and audits
Leadership of Program Data Delivery Central Monitoring
- Lead pods of Data Delivery Leads, and Central Monitors and mentor Program Data Delivery Leads
- Drive consistent execution through clear expectations and performance accountability
- Build leadership capability and pipeline through mentorship and development
- Ensure effective central monitoring for early risk detection
Risk Management Governance
- Own portfolio-level risk strategy, including identification, escalation, and mitigation
- Translate program risks into portfolio insights and proactive actions
- Lead governance forums and drive resolution of complex cross-functional issues
- Serve as escalation point for critical data delivery risks
Metrics, Insights Decision Support
- Oversee key program metrics, ensuring timely actions, resolution, and closure of identified issues
- Leverage analytics to identify trends, risks, and improvement opportunities across programs
- Provide clear, actionable portfolio insights to senior leadership, enabling informed, data-driven decisions and effective trade-off management
Cross-Functional Vendor Leadership
- Influence across Clinical Operations, Biostatistics, Safety, Systems, and vendors
- Align program execution with portfolio and enterprise priorities
- Oversee vendor performance and delivery quality at scale
Process Excellence Transformation
- Drive adoption of standardized methodologies and best practices
- Lead improvements to enhance efficiency, scalability, and quality
- Champion innovation in central monitoring and data review
- Doctorate /Masters Degree /bachelors degree with 15+ years of experience in life sciences / clinical data management
- Proven experience leading programs/portfolios in clinical data management
- Demonstrated people leadership and organizational management experience.
- 15+ years work experience in life sciences or medically related field, including 10 years of managing data on biopharmaceutical clinical research experience
- Extensive experience in Program Data Delivery and Central Monitoring models
- Strong experience in portfolio oversight across multiple global clinical trials
- Demonstrated ability to operate at both strategic and execution levels
- Experience influencing in matrixed, global environments
- Experience leading teams, transformation and modernization initiatives
- Experience engaging and working across clinical trial teams in multiple geographies to deliver global clinical trials
- Experience with managing data collection and oversight with external vendor (CROs, central labs, imaging vendors, etc.)
- Experience with risk-based monitoring models / risk-based quality management, and/or clinical site management.
Must-Have Competencies:
- Ability to lead portfolio-scale delivery and influence enterprise-level decisions
- Strong capability to identify cross-program risks and drive mitigation strategies
- Expertise in interpreting complex clinical and operational data to guide portfolio execution
- Ability to drive standardization, scalability, and innovation across programs
- Proven ability to build, develop, and lead high-performing teams across geographies
- Strong experience managing vendors and cross-functional dependencies at scale
- Ability to drive change and adoption of new operating models across the organization
Soft Skills:
- Strong executive presence and communication skills
- Ability to influence senior leadership and cross-functional stakeholders
- Strategic thinking combined with strong execution orientation
Sourced from naukri
Skills
data qualityAutomationclinical data managementclinical researchclinical trialsClinical Operationsdata cleaningAnalyticsBiotechnologyData CollectionRisk ManagementData ManagementLife Sciencesquality managementArtificial Intelligence
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
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Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
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