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Senior Manager, Feasibility

Takeda

This is a Full-time position in Boston, MA posted April 8, 2021.

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use .

I further attest that all information I submit in my employment application is true to the best of my knowledge.

n n Job Description n nSenior Manager, Feasibilityn nAre you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

Join us as a Senior Manager, Feasibility.n nAt 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 realize their potential through life-changing work.

Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.n nHere, you will be a vital contributor to our inspiring, bold mission.n n OBJECTIVES: n Conduct data-driven feasibility assessments for Phase I
– IV clinical studies, including protocol design optimization, country/site identification, enrollment strategy and modeling.

Utilize internal and external competitive intelligence data to develop data-driven study start-up forecasts, benchmarking assumptions, robust and accurate enrollment plans.

Contribute in efforts to implement innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued Feasibility and Study Start-up Services.

Participate in global initiatives representing Clinical Operations and Study Optimization in support of Takeda R&D objectives.

n ACCOUNTABILITIES: n Accountable for the development of the feasibility analyses to maximize efficiency, effectiveness, and acceleration in Takeda’s operational execution of its clinical research studies.

Ensures consistent standards are applied to the feasibility process across project portfolios and directs continuous improvement activities while developing and implementing TA-aligned strategies / approaches.

Collects and analyzes 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 study initiation 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.

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).

Define risk/ mitigation planning.

Maintains current therapeutic area knowledge and continually assesses impact of new and evolving information on operational strategies.

Exhibit the ability to perform root cause analysis and determine mitigation steps to removing critical path roadblocks related to study execution and patient enrollment.

Customer focus, attention to detail, experience with information systems and clinical trial intelligence and supporting data, extremely proficient with MS Office applications, ability to handle multiple projects.

Strong analytical competencies.

Exposure to and understanding of clinical data sets as it relates to clinical trial planning, forecasting and execution.

Act as a role model for Takeda’s values.

nThe Senior Manager, Feasibility is charged with developing a detailed plan of the enrollment strategynand site activation timelines of a given clinical trial, as well as, providing project oversight and guidance through last patient enrolled of each supported study.

The incumbent will collaborate withninternal stakeholders and utilize internal and external data sources to formulate the analyses andnstrategy, which will be presented to the Takeda study team.

Once the feasibility assessment isnagreed upon and adopted, the assessment will be used as the basis for specifications in Takeda’snRequest for Proposal (RFP) submitted to the CRO vendors.n n Technical/Functional (Line) Expertise: n Comprehensive understanding of the pharmaceutical industry and deep expertise in clinical drug development.

Demonstrated experience in conducting strategic feasibility assessments of global studies.

Demonstrated knowledge of government/international databases, open source databases or proprietary databases (e.g.

PubMed/Medline, ClinicalTrials.gov, Citeline).

Demonstrated ability to form strong working relationships with other groups within the organization essential to high level performance in this position.

Knowledge of FDA and ICH-GCP guidelines for conducting clinical research.

Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change).

Demonstrated ability to work across functions, regions and cultures.

Enterprise level leadership with the ability to inspire, motivate and drive results.

Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.

Proven skills as an effective team player who can engender credibility and confidence within and outside the company.

Ability to distil complex issues and ideas down to simple comprehensible terms.

Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.

n Decision-making and Autonomy :n Broad decision-making responsibilities: Accountable for decision making for designated function.

Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions.

Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution.

n Interaction: n Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace.

Ability to effectively implement R&D’s partnership strategy.

Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions.

n Innovation: n Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation.

Comfortable challenging the status quo and bringing forward innovative solutions.

Ability to take risks implementing innovative solutions, accelerating time to market.

n Complexity :n Ability to work in a global ecosystem (internal and external) with a high degree of complexity.

Breadth of knowledge required across therapeutic areas, indications, and/or modalities.

n EDUCATION AND SKILLS: n BS degree or international equivalent in a life science required, advanced degree preferred.

Extensive experience (= 8years) 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.

At least 5 years of direct responsibility in leading strategic feasibility assessments of global clinical research studies at a sponsor or CRO.

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 start-up strategies.

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, facilitate decision making processes to be data driven.

n WHAT TAKEDA CAN OFFER YOU: n 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs n Location and Salary Information: n Location(s): Remote Base Salary Range: $165K-$180K based on candidate professional experience level.

Employee may also be eligible for Short Term and/or Long Term incentive benefits.

Employees a