Takeda Pharmaceuticals Head of Study Site Engagement in Topeka, Kansas
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as the Head, Study Site Engagement based remotely reporting to the Head, Clinical Site Startup & Engagement.
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 accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, 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 an important contributor to our inspiring, bold mission.
Develop and execute Takeda's global trial site engagement strategy to ensure predictable delivery and establish Takeda as a preferred sponsor for clinical sites.
Oversee collaboration between Study Site Engagement (SSE) team and R&D partners, including Site Startup, study execution teams (SET), Site Budgeting and Contracting (SB&C) and CRO partners, to implement site relationship management and site monitoring activities.
Oversee onboarding, and resource management of the SSE team, including Study Site Engagement Leads and CRAs.
Oversee and ensure the productive engagement of Takeda's site-facing roles with clinical trial sites to develop lasting, collaborative relationships.
Enable study teams to conduct and ongoing delivery within timelines that contribute to predictable delivery for achieving R&D goals.
Provide guidance, oversight, and training to the Study Site Engagement (SSE) team, including Study Site Engagement Leads, SSEL Managers, CRAs, and CRA Managers, to maximize effectiveness, and acceleration in Takeda's operational execution of clinical research.
Develop and maintain appropriate processes and documentation for harmonized SSE support across Takeda's study portfolio.
Work with relevant partners to develop strategic direction of the group, develop and track measures of success.
Maintain regular information exchange within the SSE team, identify common elements of study support across regions/countries to codify and apply lessons learned, troubleshoot issues and use your expertise across the SSE team.
Establish appropriate collaboration with Global Medical Affairs (MA), Local Operating Companies (LOCs) and other R&D functions.
Ensure communication of issues to study/ program teams and senior management.
Oversee resource and talent management of SSELs and CRAs across relevant regional/country clusters to maintain quality of monitoring deliverables and achieve GDO goals.
Accountable for overall oversight of Functional Service Provider (FSP) SSELs and CRAs by country/region SSEL Managers and CRA Managers
Manage local site engagement vendors and partners to develop resourcing strategies in the country/region to and ensure consistency across the SSE organization.
Train and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops creative thinkers.
Be point of escalation for issues that arise in site engagement, escalating to Head of Clinical Site Startup & Engagement and keeping the relevant Clinical Operations Managers informed of escalations and resolutions.
Be a Subject Matter Expert and represent the SSE team in committees and projects.
Manage functional budget, including resource projections, capacity assessment, and vendor oversight and evaluation.
Align with Global/Local Medical Affairs to ensure strategy and approach for programs and studies is appropriate for meet study goals incorporating SSELs, CRAs and MSL roles.
Develop standardized R&D report depending on regional/country requirements to be distributed prior and presented during R&D council.
Distribute quarterly reports on clinical study status to relevant partners.
Collect feedback from Medical Affairs and drives process improvements of LOC Reports in collaboration with the Metrics & Reporting Team and Clinical Programs.
Work with Global/Local Medical Affairs leadership to partner of important projects and present at several meetings Stay up to date with relevant industry trends and innovations to ensure best practices in site engagement are applied across Takeda.
EDUCATION AND EXPERIENCE:
Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree advantageous.
12+ years experience in the pharmaceutical industry or clinical research organization, including 8+ years in clinical development.
Experience in people leadership and coordinating collaboration with cross functional teams, including 5+ years of line management experience.
Global/international experience required, including ability to collaborate with colleagues in other locations.
Operational experience in clinical development with direct exposure trial site engagement and relationship management.
Previous experience in the management of CRAs and familiarity with flexible resourcing models.
Previous experience building a team to partner with key stakeholders.
Multi-language skills are a plus.
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Base Salary Range: $230,000 - $280,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. 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.
This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. § 8-5-101 et seq.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
Takeda 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.
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