Senior Manager, Feasibility

Role Summary

Senior Manager, Feasibility, remotely reporting to the Director, Feasibility. This role contributes to data-driven feasibility assessments across Phase I–IV clinical studies and supports ongoing delivery of Feasibility and Enrollment Forecasting Services.

Responsibilities

• Develop feasibility analyses to maximize efficiency, effectiveness, and acceleration in operational execution of clinical research studies.
• Ensure standards are applied to the feasibility process across project portfolios and direct continuous improvement activities while developing TA-aligned strategies.
• Collect and analyze data (e.g., local treatment standards of care, available treatment options, local incidence/prevalence of disease, access to patient populations, drug landscape, historical/current clinical trial landscape) to influence protocol development, operational plans, and site selection.
• Leverage industry tools and data sources to provide data on startup timelines, past recruitment rates, and performance to assist study initiation timeline forecasting.
• Collaborate with internal stakeholders to integrate data and provide clear feasibility recommendations, strengthen trend analysis, identify root causes, and deliver recommendations across study teams and programs to accelerate study execution.
• Monitor actual patient enrollment performance of assigned studies and re-forecast enrollment models to adjust for new factors (e.g., changes in drug landscape, protocol amendments, screen failure rates).
• Determine risk/mitigation planning and maintain current therapeutic area knowledge to assess impact on operational strategies.
• Perform root cause analysis and determine mitigation steps to remove roadblocks related to study execution and patient enrollment.
• Provide data-driven recommendations to assist decision making at the study level and program level to help define asset strategy.
• Develop deep insights, uncover unmet needs, and collaborate within a global matrixed team; act as a role model for Takeda’s values.

Qualifications

• Required: BS degree or international equivalent; life science preferred.
• Required: At least 4 years of direct responsibility in leading strategic feasibility assessments or equivalent data analytics roles in a healthcare or clinical research setting at a sponsor or CRO.
• Required: 6+ years of experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization with increasing responsibility within a pharmaceutical company, CRO, or relevant industry vendor.
• Required: Direct experience in the pharmaceutical industry or related field.
• Required: Experience with leading-edge trial optimization vendors, tools, and methods.
• Required: Proficiency with software models and database structures.
• Required: Expertise in principles driving country/site identification, feasibility and study startup strategies.

Education

• BS degree or international equivalent required; in life science (preferred).