Head of Feasibility and Study Start Up
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.
We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
- Results Driven
- Team Player
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By focusing R&D efforts on four therapeutic areas and other targeted investments, our aim is to thrive at the cutting edge of innovation that solves unmet medical needs, through internal R&D and in collaboration with cross-industry partners. We have the scale and expertise to be a leading global, Values-based, R&D-driven biopharmaceutical company with dynamic, focused R&D efforts.
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Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.
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Head of 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 Head of Feasibility and Study Start-Up at our Boston, MA site.
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.
- Oversees the analysis of clinical trial intelligence data and its application to effectively conduct protocol design optimization, robust study feasibility assessments, and oversight of country/site identification and selection activities.
- Drives rapid, accurate, and robust data-driven study start-up forecasts, benchmarking assumptions, robust scenarios and accurate planning.
- Creates and implements innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued Feasibility and Study Start-up Services.
- Establishes a strategic vision and lead the team in feasibility and study start-up to maximize efficiency, effectiveness, and acceleration in Takeda’s operational execution of clinical research.
- Develop or pursue new and effective data analytics that support clinical project teams.
- Design and oversee delivery of quality pilot programs, analyses of value add, and business case development of innovation for broader adoption.
- Liaise and collaborate with non- R+D functions to drive investigator partnerships to Takeda’s interface as it pertains to achievement of R+D goals.
- Stay abreast of relevant industry and consumer changes.
- Ensure a model for staff to apply lessons learned on current best practices.
- Leverages advanced knowledge as subject matter expert and through process ownership drives concepts and theories within R+D.
- Provides guidance, 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.
- Supports development of systems, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility of countries and sites.
- Ensures consistent standards are applied to the feasibility and study start-up process across project portfolios and supports continuous improvement activities while developing and implementing TA-aligned strategies / approaches.
- Drives 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.
- Leverages 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 evaluates and communicates 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.
- In partnership with internal stakeholders- synthesizes, interprets and integrates 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.
- Oversees and ensures the successful delivery of global (end-to-end) feasibility activities (strategy, plans, activities, timelines, synthesis of feasibility insights and presentation to study teams) at program/study level. Enable study teams to conduct effective and ongoing delivery within timelines that contribute to operational planning / decisions resulting in predictable delivery for achieving R&D goals.
- Technical/Functional (Line) Expertise
- Comprehensive understanding of the pharmaceutical industry and deep expertise in clinical drug development.
- Good understanding of communications, operations, legal, IP, finance, accounting, tax, HR, compliance, facilities management, EH&S, with the ability to traverse these varied disciplines and develop effective and cohesive strategic and operational solutions.
- 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.
- Executive leadership presence and confidence.
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
- Ability to develop a Global Workforce and Talent strategy.
- Decision-making and Autonomy
- Broad decision making responsibilities:
- Ability to make highly complex decisions that impact the enterprise.
- 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.
- Accountable for designing and implementing vision and strategy for designated scope.
- Broad decision making responsibilities:
- 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.
- Effectively represent Takeda in high-level negotiations with the ability to resolve conflict in a constructive manner.
- Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions.
- 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.
- 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.
EDUCATION, EXPERIENCE, AND SKILLS:
- BS degree required, advanced degree preferred with 12+ years of experience.
- Extensive experience in Clinical Operations, Data Analytics, global feasibility, and trial optimization (greater than 7 years) with evidence of increasing responsibility within a pharmaceutical company, CRO or other relevant vendor required.
- Expertise 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.
- Direct experience in the pharmaceutical industry or related field required.
- Previous experience leading a medium to large organization and partnering as well as influencing senior-level management and key stakeholders is a plus.
- Ability to strongly 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.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
- Willingness to travel to meetings including overnight trips.
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
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
Empowering Our People to Shine.
Job ID R0023439