Head, Clinical Trial Management

Company: Takeda Pharmaceuticals
Location: Austin
Posted on: September 24, 2022

Job Description:

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as the Head, Clinical Trial Management in Cambridge, MA or remotely reporting to the Head, Oncology and Cell Therapy Clinical Operations.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:

• Support clinical operations strategy, and management of global clinical programs by overseeing professional development, resourcing, training, and allocation of Clinical Operations Managers (COMs) and Clinical Trial Associates (CTAs) across Oncology and Cell Therapy studies.
• Oversee direct line management of COM Managers and CTA Managers.
• Oversee COM and CTA allocation across Oncology and Cell Therapy portfolios to achieve GDO goals.
• Oversee the execution of Oncology & Cell Therapy studies in a matrix management structure to ensure compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs).ACCOUNTABILITIES:
  • Provide management of Oncology and Cell Therapy COM Managers and CTA Managers in managing COMs and CTAs, including hiring/staff selection and assignment of individual studies, resource allocation, onboarding, completion of goals, development plans, performance reviews, and Talent Management.
  • Oversee COM Managers, CTA Managers, COMs, and CTAs according to the needs of Oncology & Cell Therapy Clinical Operations Program Leads to ensure execution of assigned studies.
  • Ensure appropriate training programs for COMs and CTAs to deliver operational consistency and support to operational teams.
  • Create a pipeline for COM and CTA talent with a clear career path and options to progress to COM Manager, CTA Manager roles, or other roles within Clinical Operations (e.g., COMs).
  • Establish creative sources of Clinical Operations talent and new recruiting mechanisms to support the pipeline of CTAs and COMs.
  • Ensure compliance of assigned staff to the training of quality standards (including Takeda SOPs, ICH GCP, and local regulations) and inspection readiness in the execution of Takeda studies and trials.
  • Mentor COM Managers and CTA Managers and oversee coaching of new hires in navigating career progression options within Takeda.
  • Lead to direct reports, ensuring employees follow corporate policies and following up with management.
  • Ensure compliance of employees with pre-defined roles and responsibilities within a matrix management structure.
  • Manage Oncology and Cell Therapy Clinical Operations functional level resource evaluations for study and program management (in collaboration with therapeutic area leads and COPLs) to ensure resources are available for providing clinical programs.
  • Maintain a positive work environment, building partnerships and modeling teamwork, communicating to the teams and partners in an open, balanced, and objective manner.
  • Lead Oncology and Cell Therapy Clinical Operations programs (including lessons learned process) to develop creative processes and technologies to grow operations and reduce operating costs; Support functional strategic projects.EDUCATION AND EXPERIENCE:
    • Bachelor's Degree or international equivalent required, Life Sciences preferred.
    • 15+ years of experience in the pharmaceutical industry or clinical research organization, including 12+ years in clinical study management/oversight.
    • 6+ years of line management experience including management of senior staff with accountability to therapeutic area development teams (matrix organization) and management of staff across multiple sites/regions.
    • Experience in people leadership, managing global teams, and coordinating collaboration with teams.
    • Global/international experience required, including the ability to collaborate with colleagues and staff in other locations
    • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.Base Salary Range: $230,000 - $280,000 , based on the candidate's 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 seqThis position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.EEO 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#LI-Remote

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