Manager, Feasibility

Takeda

2d • Remote

About The Position

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Manager, Feasibility based remotely reporting to the Director, 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, with limited supervision. Utilize internal and external competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, robust and accurate enrollment plans. Participate in efforts to implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of Feasibility and Enrollment Forecasting Services. Participate in global initiatives representing CSS&E and GDO in support of Takeda R&D objectives. ACCOUNTABILITIES: Accountable, in collaboration with Director, Feasibility and/or Sr. Manager, Feasibility for the development of the feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda’s operational execution of its clinical research studies. Ensures consistent standards are applied to the feasibility process across project portfolios and directs continuous improvement activities while developing and implementing TA-aligned strategies / approaches. Collects and analyzes internal and external 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 define an optimal 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, start-up cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting. In partnership with internal stakeholders- synthesize, interpret and integrate data and information to provide clear feasibility recommendations to strengthen data-driven decision making, analyze trends, identify root causes, and provide actionable recommendations across study teams and programs to accelerate study execution. Monitor actual patient enrollment performance of assigned studies. In collaboration with the Director, Feasibility and 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). Define risk/ mitigation planning. Works with Feasibility colleagues and study team members to build and expand therapeutic area/indication knowledge. Exhibit the ability to perform root cause analysis and determine mitigation steps to removing critical path roadblocks related to study execution and patient enrollment. Ability to provide data-driven recommendations to assist with decision making at a study level. Develop strong analytical competencies including the use of clinical data sets to facilitate trial planning, forecasting, and modeling. Act as a role model for Takeda’s values.

Requirements

• BS degree or international equivalent required; in a life science preferred
• 4+ years in Clinical Operations, Data Analytics, global feasibility, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor required.
• At least 2 years of direct responsibility in leading strategic feasibility assessments of global clinical research studies at a sponsor or CRO or equivalent data analysis responsibilities in a healthcare or pharmaceutical setting.
• 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 start-up strategies.
• Direct experience in the pharmaceutical industry or related field required.
• Ability to demonstrate and explain the rationale for country and site recommendations based on a data-driven approach.

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, with limited supervision.
• Utilize internal and external competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, robust and accurate enrollment plans.
• Participate in efforts to implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of Feasibility and Enrollment Forecasting Services.
• Participate in global initiatives representing CSS&E and GDO in support of Takeda R&D objectives.
• Accountable, in collaboration with Director, Feasibility and/or Sr. Manager, Feasibility for the development of the feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda’s operational execution of its clinical research studies.
• Ensures consistent standards are applied to the feasibility process across project portfolios and directs continuous improvement activities while developing and implementing TA-aligned strategies / approaches.
• Collects and analyzes internal and external 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 define an optimal 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, start-up cycle time, query rate, protocol deviations, inspection results) to assist project teams with study initiation timeline forecasting.
• In partnership with internal stakeholders- synthesize, interpret and integrate data and information to provide clear feasibility recommendations to strengthen data-driven decision making, analyze trends, identify root causes, and provide actionable recommendations across study teams and programs to accelerate study execution.
• Monitor actual patient enrollment performance of assigned studies.
• In collaboration with the Director, Feasibility and 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).
• Define risk/ mitigation planning.
• Works with Feasibility colleagues and study team members to build and expand therapeutic area/indication knowledge.
• Exhibit the ability to perform root cause analysis and determine mitigation steps to removing critical path roadblocks related to study execution and patient enrollment.
• Ability to provide data-driven recommendations to assist with decision making at a study level.
• Develop strong analytical competencies including the use of clinical data sets to facilitate trial planning, forecasting, and modeling.
• Act as a role model for Takeda’s values.

Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives.
• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees