Senior Manager, Feasibility
Company: Takeda Pharmaceutical
Posted on: May 9, 2022
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knowledge.Job DescriptionSenior Manager, FeasibilityAre 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,
- 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
- 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
- Develop the feasibility analyses to maximize effectiveness, and
acceleration in Takeda's operational execution of its clinical
- 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
- 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
- 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
- Experience with leading edge trial optimization vendors, tools
- Proficiency with software models and database structures.
- Expertise in principles driving country/site identification,
feasibility and study startup strategies.WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsLocation and Salary Information:
- Location(s): Remote
- Base Salary Range: $165K-$180K based on candidate professional
experience level."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 ShineDiscover more at
takedajobs.comNo Phone Calls or Recruiters PleaseEEO
StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Hoboken , Senior Manager, Feasibility, Executive , Hoboken, New Jersey
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