Role Summary
Senior Manager, Feasibility (remote) reporting to the Director, Feasibility. A patient-focused, innovation-driven role contributing to Takeda’s R&D goals by leading data-driven feasibility assessments and enrollment forecasting for clinical studies.
Responsibilities
- Conduct data-driven feasibility assessments for Phase I–IV clinical studies, including protocol design optimization, country/site feasibility and selection, enrollment strategy, and modeling.
- Use competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, and accurate enrollment plans.
- Contribute to implementing processes, methodologies, data and technologies to ensure ongoing delivery and improvement of Feasibility and Enrollment Forecasting Services.
- Participate in and/or lead global projects representing CSS&E and GDO to support Takeda R&D goals.
- Develop feasibility analyses to maximize efficiency, effectiveness, and acceleration in operational execution of clinical 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 standards of care, treatment options, disease incidence, population access, drug landscape, historical trial data) to inform protocol development and site selection.
- Utilize industry tools and data sources to provide data on startup timelines and recruitment performance to assist study initiation forecasting.
- Integrate data with internal stakeholders to provide clear feasibility recommendations and drive data-driven trend analysis across study teams.
- Monitor actual enrollment performance; re-forecast enrollment models in collaboration with study teams and CRO to adjust for new factors.
- Determine risk/mitigation planning and maintain current therapeutic area knowledge to inform operational strategies.
- Perform root cause analysis to remove roadblocks in study execution and enrollment; provide data-driven recommendations at study and program levels.
- Collaborate within a global matrixed team to develop insights and uncover unmet needs; act as a role model for Takeda’s values.
Qualifications
- BS degree or international equivalent required; in life science preferred.
- At least 4 years of direct responsibility in leading strategic feasibility assessments or equivalent data analytics roles in healthcare or clinical research at a sponsor or CRO.
- 6+ years of experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization with increasing responsibility in pharma, CRO, or relevant vendors.
- Direct experience in the pharmaceutical industry or related field.
- Experience with leading-edge trial optimization vendors, tools and methods.
- Proficiency with software models and database structures.
- Expertise in principles driving country/site identification, feasibility and study startup strategies.
Education
- BS degree or international equivalent required; in life science (preferred).
- Direct experience in the pharmaceutical industry or related field.