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 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:

Conduct data-driven feasibility assessments for Phase I – IV clinical studies, including protocol design optimization, country/site identification, enrollment strategy and modeling.
Use all competitive intelligence data to develop data-driven study startup forecasts, benchmarking assumptions, and accurate enrollment plans.
Contribute in efforts to implement creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Feasibility and Study Startup Services.
Participate in global projects representing Clinical Operations and Study Optimization to support Takeda R&D goals.

ACCOUNTABILITIES:

Develop the feasibility analyses to maximize 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.
Maintain the patient enrollment forecast from a strategic perspective. 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.
Promote unbiased data insights into clinical trials operational planning.
Develop deep insights, uncover unmet needs, collaborate within a global matrixed team.
Explain data, facilitate decision-making processes to be data-driven.

EDUCATION AND SKILLS:

BS degree or international equivalent in life science.
At least 5 years of direct responsibility in leading strategic feasibility assessments of global clinical research studies at a sponsor or CRO.
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.
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.

WHAT TAKEDA CAN OFFER YOU:

Base Salary Range: $165,000 to $180,000. 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.