Director, Feasibility and Enrollment Forecasting

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Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Feasibility and Enrollment Forecasting based in Cambridge, MA or remotely reporting to the Head, Feasibility and Enrollment Forecasting.

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, encourage innovation, 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.

As a Director Feasibility and Enrollment Forecasting, you will ensure the successful delivery of global feasibility and country/site selection activities (strategy, plans, timelines, synthesis of feasibility insights, utilization of data-driven approaches, and presentation to study teams) at program/study level. You will also enable study teams to conduct effective and ongoing delivery within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals.

GOALS:

• Lead the execution of robust study feasibility assessments, protocol design optimization, and country/site identification and selection activities.
• Manage data-driven development of study timelines including start-up forecasts and enrollment projections; taking in to account benchmarking/early assumptions, historical trial performance, multiple scenarios, and application of appropriate algorithms to support accurate planning.
• Lead efforts to implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued Feasibility and Forecasting services.
• Lead global initiatives representing Global Development Operations and Clinical Site Start-up and Engagement in support of Takeda R&D objectives.

ACCOUNTABILITIES:

• Lead the implementation of the feasibility and forecasting strategic vision to maximize efficiency, effectiveness, and acceleration of Takeda’s operational execution of clinical research.
  • Assist with the development of new and effective data analytics that support clinical project teams.
  • Direct delivery of quality pilot programs, and business case development for broader adoption.
  • Collaborate with non- R+D functions to drive investigator partnerships at Takeda.
  • Interface with internal and external stakeholders as it pertains to achievement of R+D goals.
  • Stay abreast of relevant industry and consumer changes.
  • Ensure staff applies lessons learned to current best practices.
• Oversee and train the Feasibility and Forecasting team, delivering activities in support of Clinical Programs, including data and methodologies for protocol feasibility, country and site identification/selection, and enrollment modeling.
• Develop systems, processes, and work practices that drive rapid, accurate and robust feasibility and performance assessments of programs, protocols, countries, and sites.
• Apply consistent standards to the feasibility and forecasting process across the Takeda portfolio and direct continuous improvement activities while developing and implementing TA-aligned strategies/approaches.
• Direct the collection and analysis of 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 country and site selection.
• Communicate financial implication of the use of specialty vendors (feasibility and data providers) and provide protocol-specific feasibility strategies to key stakeholders.
• Liaise with various Takeda owners of relationship management and engagement, to collaborate and expand the pool of investigator participation in current/future trials to reach study goals.
• 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.
• Maintain current therapeutic area knowledge and continually assesses impact of new and evolving information on operational strategies.
• Line manager for Feasibility and Enrollment Forecasting staff.

EDUCATION AND EXPERIENCE:

• BS degree or international equivalent required.
• Advanced degree is preferred.
• Direct experience in the pharmaceutical industry or related field required.
• 5 or more years or experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or other relevant vendor required.
• Experience with leading edge trial feasibility and optimization vendors, tools, and methods.
• Proficiency with software models and database structures.
• Expertise in principles driving country/site identification, feasibility and selection strategies.
• Previous experience leading an organization and partnering as well as influencing senior-level management and key stakeholders is a plus.
• Ability to demonstrate, interpret, explain, represent, and drive unbiased data-driven insights into clinical trial operational planning.
• Ability to explain data and facilitate decision making processes that are data-driven.

WHAT TAKEDA CAN OFFER YOU:

• Base Salary Range: $$160,300 - $229,000. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

"This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq."

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