Director Feasibility and Study Start Up
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director Feasibility and Study Start Up in our Cambridge, MA office.
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 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.
Here, you will be a vital contributor to our inspiring, bold mission.
As a Director Feasibility and Study Start Up working on the Global Clinical Operations team, you will be empowered to lead efforts to implement and innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued Feasibility and Study Start-up Services. A typical day will include:
Lead and direct the execution of protocol design optimization, robust study feasibility assessments, and oversight of country/site identification and selection activities.
Accountable for the execution of data-driven study start-up forecasts, benchmarking assumptions, robust scenarios and accurate planning.
Initiates, develops, leads and/or participates in global initiatives representing Clinical Operations and Study Optimization in support of Takeda R&D objectives.
Accountable for the implementation of the feasibility and study start-up strategic vision to maximize efficiency, effectiveness, and acceleration in Takeda's operational execution of clinical research.
Provides oversight, and training to the Feasibility and Study Start-up team, delivering activities in support of Clinical Programs, including data and methodologies for protocol feasibility, country and site identification/selection, study start-up planning, and modeling.
Directs the collection and analysis 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 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
Systematically evaluate and communicate financial impacts of specialty vendors (feasibility and study start-up) and feasibility strategies to key stakeholders.
Liaise with various Takeda owners of relationship management and engagement, to collaborate and expand the pool of investigator participation in current / future trials to reach study goals
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
BS degree or international equivalent required, advanced degree is highly desirable.
At least 5 years' experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization within a pharmaceutical company, CRO or relevant vendor required.
Experience with leading edge trial optimization vendors, tolls and methods.
Proficiency with software models and database structures.
Expertise in principles driving country/site identification, feasibility and study start-up strategies.
Previous experience leading an organization and partnering as well as influencing senior-level management and key stakeholders is a plus.
Ability to explain data, facilitate decision making processes to be data driven
Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
WHAT TAKEDA CAN OFFER YOU:
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
Location and Salary Information:
Base Salary Range: $195K-$215K based on candidate professional experience level. Employee may also be eligible for Short Term and/or Long Term incentive benefits. Employees are eligible to participate in Medical, Dental. Vision, Life Insurance, 401(k), Charitable Contribution Match, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off
If candidate is not eligible for any benefits or other comp., those can be excluded
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Takeda Pharmaceutical Company Ltd