Senior Manager, Feasibility

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• 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 all competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, and accurate enrollment plans.

• Contribute to implementing creative processes, methodologies, data and technologies to ensure ongoing delivery and continuing 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.

ACCOUNTABILITIES:

• Develop feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda's operational execution of its 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 all data (e.g. local treatment standard of care, available treatment options approved/reimbursed, local incidence/prevalence of disease, access to targeted patient population, drug landscape, historical/current clinical trial landscape) to influence and inform protocol development, operational plans, and establish a geographic country footprint and proposed sites for participation in a clinical study.

• Leverage leading industry tools and data sources to provide data on startup timelines, past recruitment rates and performance (data quality, startup cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting.

• In partnership with internal stakeholders- combine and integrate data to provide clear feasibility recommendations to strengthen data-driven trend analysis, identify root causes, and provide relevant recommendations across study teams and programs to accelerate study execution.

• Monitor actual patient enrollment performance of assigned studies. In collaboration with the Takeda study team and CRO, responsible for re-forecasting patient enrollment models to adjust for new influence factors (e.g. change in drug landscape, protocol amendment, increased screen failure rate).

• Determine risk/ mitigation planning.

• Maintain current therapeutic area knowledge and assess impact of evolving information on operational strategies.

• Exhibit the ability to perform root cause analysis and determine mitigation steps to removing roadblocks related to study execution and patient enrollment.

• Ability to provide data-driven recommendations to assist with decision making at a study level as well as provide program level support to help define asset strategy.

• Through strong analytical skills, develop deep insights, uncover unmet needs, collaborate within a global matrixed team.

• Act as a role model for Takeda’s values.

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EDUCATION AND EXPERIENCE:

• 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 role(s) in a healthcare or clinical research setting at a sponsor or CRO.

• 6+ years of experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor.

• 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.