Career Category
Clinical Development
Job Description
The Director Data Delivery & Insights role drives end-to-end accountability for data management within the therapeutic area, ensuring databases and datasets are built, maintained, and locked to the highest quality standards, with timelines met and actionable, reliable data delivered for interim and final analyses.
The Director leads and develops the therapeutic area team by managing Program Data Delivery Leads, fostering consistency in ways of working, acting as the point of escalation, and building a culture of accountability, collaboration, and continuous improvement across the therapeutic area.
This critical leader represents the therapeutic area as the senior data management voice, partnering cross-functionally with GDO and non-GDO stakeholders to reflect enterprise strategy, contribute therapeutic area perspectives to global initiatives, and ensures Amgen’s data management strategy is consistently applied.
Roles & Responsibilities:
Set the therapeutic area data delivery strategy and ways of working and align study teams to it.
Review and approve program-level data management plans, integrated data review approaches, and lock plans across the TA.
Run TA delivery forums to compare studies, surface risks, and drive consistent practices across Program Data Delivery Leads, Study Data Delivery Leads, and Central Monitors.
Prioritize and allocate Study Data Delivery Leads, Central Monitors, and support resources across the TA based on risk and milestones.
Track TA-level delivery metrics (database readiness, LPLV-to-lock cycle time, unlocks, query aging) and drive corrective actions.
Escalate cross-study issues and remove roadblocks with Clinical Operations, Biostats, Safety, and Systems teams.
Coach Program Data Delivery Leads and ensure consistent feedback, development plans, and succession for critical roles.
Harmonize KRI/QTL usage and IDRP conventions across the TA in partnership with stakeholders.
Lead TA readiness for interim and final analyses, chairing lock readiness reviews and aligning dependencies.
Represent the TA in governance and portfolio reviews, communicating status, risks, and decisions.
Develop annual group goals and manage resource and budget for the TA.
Basic Qualifications and Experience:
Doctorate Degree and 15+ years of life science, computer sciences, business administration experience OR
Master’s Degree and 18+ years of life science, computer sciences, business administration experience OR
Bachelor’s degree and 18+ years of life science, computer science, business administration experience
In addition to meeting at least one of the above requirements, you must have a minimum of 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.
Preferred Experience:
12+ years work experience in life sciences industry, particularly focusing on clinical trial work, including 10+ years of biopharmaceutical clinical research experience obtained at a biotech or pharmaceutical company
Experience managing multiple teams / direct reports across multiple geographies
Experience at or oversight of outside clinical research vendors (CRO’s, central labs, imaging vendors, etc.)
Functional Competencies:
Must-Have Competencies:
Experience leading cross-functional / cross-geography / cross-trial teams, ensuring operational excellence and smooth decision-making; ability to escalate and resolve challenges in alignment with global study strategy priorities.
Proficient in overseeing resource and budget allocation in adherence to functional financial principles for optimal, cost effective resource planning in aligned to global clinical priorities.
Experience in delivering portfolio/cross-study level, budgets, timelines, and performance metrics (time, cost, quality) aligned to global / functional priorities.
Demonstrates clear understanding of how to build collaborative networks across cross-functional teams, senior management, and external stakeholders, internally and externally to drive efficiency across processes.
Experience in assessing internal capabilities and identifying key capabilities to build training content, monitoring skill improvement, and drive competency builds across function and within teams.
Experience driving and leading organizations through cross-functional change initiatives such as identifying solutions to problems and innovating and change strategies and structure to meet future needs.
Big picture, pro-active thinking with the ability to assess broad impacts across multiple product portfolios to identify innovative solutions.
Ability to consolidate and interpret global data trends and apply those in strategic design and decision-making for a clinical portfolio.
Proficient in driving and leading continuous improvement initiatives for team's working practices, ensuring cross-functional adoption of new processes.
Experience in establishing strategic partnerships with external vendors at an enterprise / portfolio level ensuring optimized utilization of external resources.
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