Primary Responsibilities:
- Design, define, and advance a next-generation clinical and portfolio insights platform for real-time reporting and analytics across studies, programs, and the portfolio.
- Establish and govern a single “source of truth” by integrating internal and external operational data (e.g., CRO/vendor feeds, benchmarking sources) with data quality, lineage, and access controls.
- Architect a centralized operational data infrastructure (e.g., data lake/warehouse, semantic layer, data products) with self-service business intelligence.
- Integrate operational planning data with actuals for planned vs. actual comparisons (timelines and costs).
- Implement scalable operational data governance (metadata, master data, standards) aligned with R&D operating models and GxP expectations.
- Develop standardized analytical frameworks and methodologies (metric definitions/specifications, visualization standards).
- Define and operationalize study/program/portfolio KPIs and performance analytics (cycle times, activation/enrollment velocity, budget adherence, quality/deviation indicators, vendor performance, milestone attainment).
- Create advanced analytics and simulation capabilities to predict and optimize timelines, costs, and risks (e.g., slippage forecasting, enrollment trajectories, budget/operational risks).
- Design and deploy AI/ML-enabled prescriptive analytics with actionable recommendations.
- Enable portfolio-wide scenario modeling and resource planning for governance decisions.
- Develop predictive country and site selection analytics to optimize trial delivery (start-up speed, enrollment yield, data quality, cost) and feasibility.
- Create a study-level insights platform providing site- and PI-level insights (enrollment health, quality, cost, competitive trial density).
- Design integrated resource management to analyze demand vs. actuals, predict AI-enabled resource demand, and flag capacity bottlenecks in partnership with HR and functional leaders.
- Drive change management and adoption of analytics embedded in business rhythms (governance reviews, QBRs, portfolio prioritization, study health checks).
Qualifications / Education:
- Bachelor’s degree in a quantitative or life sciences field. Preferred: Master’s or PhD in Data Science, Biostatistics, Operations Research, or related; MBA a plus.
- 15+ years in biopharma/biotech R&D with focus on clinical operations analytics, portfolio management, or development operations; 5+ years leading multi-disciplinary teams.
Required Skills / Experience:
- Proven track record building enterprise data/analytics platforms and single-source-of-truth solutions integrating internal and external/vendor data.
- Expertise with portfolio/program/study KPIs, operational planning, plan vs. actual analysis, and scenario modeling for timelines, costs, risks, and resources.
- Hands-on advanced analytics/ML (forecasting, simulation, optimization) and translating algorithms into operational tools.
- Strong understanding of the clinical development lifecycle (feasibility, site activation, enrollment, data management, monitoring, close-out) with familiarity with GCP/GxP, data privacy, and validation for decision-support tools.
- Executive presence; ability to influence senior stakeholders and translate complex analytics into clear narratives.
- Exceptional verbal/written communication; ability to interpret and communicate complex data to diverse audiences.
- Ability to influence without direct authority in a matrix environment; hands-on management style; adaptability and integrity.
Preferred (Plus):
- Site/country selection analytics, enrollment prediction, vendor performance analytics.
- Familiarity with R&D systems (CTMS, EDC, eTMF, RTSM, safety, eCOA), enterprise planning tools, and HR capacity planning.
- Background in data governance (metadata, MDM) and data product management/adoption at scale.