Job Information
Takeda Pharmaceuticals Director, Regional Lead, Study Site Engagement in Topeka, Kansas
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Job Description
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Study Site Engagement, Regional Lead based remotely reporting to the Head, Study Site 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.
GOALS:
The Study Site Engagement Regional Lead (SSE-RL) provides leadership, and support for the activities of the country-based Study Site Engagement Leads (SSEL) within their assigned region to deploy Takeda's global trial site engagement strategy.
Establish collaboration with Global/Regional Medial Affairs, LOCs, CROs, and other R&D Functions to maintain relationships between Takeda, study sites and the CRO.
Provide prioritization of activities to the global SSE team to achieve study timelines and milestones.
Provide input and intelligence to Program and Study strategies for country and site identification, feasibility, site selection, study recruitment, and DE&I.
ACCOUNTABILITIES:
With the support of the Head of SSE, provides guidance, oversight, and training to the Study Site Engagement (SSE) team, including Study Site Engagement Leads, SSEL Project Leads, SSEM, CRAs, and CRA Managers, to maximize efficiency and acceleration in Takeda's operational execution of clinical research.
Develop appropriate processes and documentation for harmonized SSE support across Takeda's study portfolio.
Work with Head of SSE to develop strategic direction of the group, implement Takeda site engagement strategy, and 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 knowledge across the SSE team.
Establish appropriate collaboration with Global Medical Affairs (MA), Local Operating Companies (LOCs) and other R&D functions and external partners such as KOLs and local/regional CRO personnel.
Ensure communication of issues to study/ program teams and senior management.
Responsible for resource and talent management of SSELs and CRAs across relevant regional/country clusters to achieve monitoring deliverables and GDO goals.
As applicable in assigned region, maintain oversight of Functional Service Provider (FSP) SSELs and CRAs.
Develop site engagement resourcing strategies and ensure understanding of tactics across the SSE organization.
Mentor supervised employees (direct and indirect reports) to create a culture that shapes creative thinkers.
Be the point of escalation for issues that arise in site engagement, escalating to Head of Study Site Engagement and keeping the relevant Clinical Operations Managers informed of escalations and resolutions.
Be the Subject Matter Expert and represent the SSE team in committees and projects.
Provide input to Head SSE for development of functional budget, including resource projections, capacity assessment, and vendor oversight and evaluation.
In assigned region and together with the Head, SSE:
Accountable for development of 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 drive 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 multiple 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/Scientific degree or comparable background highly advantageous.
12+ years' experience in the pharmaceutical industry or clinical research organization, including 8+ years in clinical development or comparable role(s).
4+ years of line management experience, including people leadership and coordinating collaboration with cross functional teams.
Operational experience in clinical development with direct exposure trial site engagement and relationship management.
Knowledge of ICH/GCP Guidelines and local regulations for clinical trials.
Experience in monitoring or management of CRAs.
Familiarity with flexible resourcing models is a plus.
Multi-language skills are a plus.
ADDITIONAL INFORMATION:
- Travel up to 10-20%. Domestic and international travel is expected for this position following regional assignments and location of meetings, congresses and training.
WHAT TAKEDA CAN OFFER YOU:
Base Salary Range: $200,000 - $225,000. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days and Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.
EEO Statement
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.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
#LI-Remote