Associate 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:

• Manage feasibility activities at a program and/or asset level with minimal oversight by the Therapeutic-aligned Director of Feasibility.

• Conduct data-driven feasibility assessments for Phase I – IV clinical studies, including protocol design optimization, country/site identification, enrollment strategy and modeling across therapeutic areas.

• Utilize internal and external competitive intelligence platforms/tools to develop benchmark assumptions that enable data-driven program/study timeline projections, country and site identification, and robust enrollment forecasts.

• Collaborate with operational leads and other cross-functional stakeholders to increase understanding of metrics and forecasts particularly with respect to enrollment timeline analytics.

• Contribute in efforts to implement innovative processes, methodologies, data and technologies that ensures continuous improvement and innovation of valued Feasibility services.

• Participate in or lead global initiatives representing Clinical Site Startup & Engagement (CSSE) in support of Takeda R&D objectives.

ACCOUNTABILITIES:

• Contribute to Clinical Development Plans , providing directional timeline estimates and high-level enrollment projections driven by available historical trial/industry performance data.
• Accountable for the development of feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda’s operational execution of its clinical research studies.
• May be responsible for the oversight and direction of Feasibility staff contributing to asset(s) for which the AD is responsible.
• Ensures consistent standards are applied to the feasibility process across the portfolio and directs continuous improvement activities while developing and implementing TA-aligned strategies/approaches.
• Develops TA/Indication expertise and act as feasibility subject matter expert in order to contribute to protocol design discussions. Utilize available historical and current standard of care information, epidemiology data as well as investigative site feedback to influence and inform protocol development, and operational plans.
• Lead country and site selection process to ensure data-driven decisions are made through: Collection, analysis, and presentation 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 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) as well as use internal tools (e.g., SPARK) to provide project/study teams with study initiation and enrollment 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. 
• Regularly reviews ongoing study performance in relation to projected study timelines and, in collaboration with the Takeda study team and CRO, is 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). 
• Identifies study performance risk and assist study team in mitigation planning. Exhibit the ability to perform root cause analysis and determine mitigation steps to removing critical path roadblocks related to study execution and patient enrollment.
• Strong analytical competencies. Exposure to and understanding of clinical data sets as it relates to clinical trial planning, forecasting and execution.
• Customer focus, analytical mindset with attention to detail. experience with information systems and clinical trial intelligence and supporting data,
• Demonstrated experience managing and collaborating in a matrix work environment. Ability to direct activities and influence outcomes without direct authority. Ability to work independently and handle multiple projects.
• Demonstrated business acumen especially in relation to interacting with higher-level staff in an efficient, effective, and respectful manner.
• Extremely proficient with MS Office applications.
• Act as a role model for Takeda’s values.

​

EDUCATION AND EXPERIENCE:

• BS degree or international equivalent in a life science required, advanced degree preferred.
• 8 or more 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 required.
• 7 or more years of direct responsibility in leading strategic feasibility assessments of global clinical research studies at a sponsor or CRO including at least 2 years of country and site selection responsibilities.
• Experience with leading edge trial optimization vendors, tools, and methods.
• Proficiency with software models and database structures.
• Expertise in principles of data-driven country/site identification and selection, feasibility, and study start-up planning.
• Direct experience in the pharmaceutical industry or related field required.
• Ability to demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational planning.
• Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team.
• Ability to explain data in order to facilitate decision making processes to be data driven.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. 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.