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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 Senior 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.
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.
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.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - Virtual
U.S. Base Salary Range:
$137,000.00 - $215,270.00
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-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.
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
Job Exempt
YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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