at Takeda Pharmaceuticals in Springfield, Illinois, United States
Job Description
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Job Description
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Associate Director, Feasibility based Cambridge, MA or remotely reporting to the Director, Feasibility and Study Start Up.
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.
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:
+ Provide directional timeline estimates and high-level enrollment projections driven by available historical trial/industry performance data for Clinical Development Plans.
+ Develop of feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda’s operational execution of its clinical research studies.
+ Oversee and direct Feasibility staff contributing to asset(s) for which the AD is responsible.
+ Ensure consistent standards are applied to the feasibility process across the portfolio and direct continuous improvement activities while developing and implementing TA-aligned strategies/approaches.
+ Develop TA/Indication expertise and be feasibility subject matter expert 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.
+ Partner with internal stakeholders to 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.
+ Review ongoing study performance in relation to projected study timelines and, in collaboration with the Takeda study team and CRO, re-forecast patient enrollment models to adjust for new influence factors (e.g., change in drug landscape, protocol amendment, increased screen failure rate).
+ Identify study performance risk and assist study team in mitigation planning. Perform root cause analysis and determine mitigation steps to removing critical path roadblocks related to study execution and patient enrollment.
EDUCATION AND SKILLS:
+ Bachelor’s 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.
+ 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.
WHAT TAKEDA CAN OFFER YOU:
+ Base Salary Range: $143,500 – $205,000. 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.”
Empowering Our People to Shine
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EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Massachusetts – Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
\#LI-Remote
