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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

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.

OBJECTIVES:

• Fully dedicated and responsible for the overarching cell therapy platforms and their respective clinical operations strategies, execution, and management of clinical programs as defined in the Clinical Development Plan (CDP).
• Responsible for Oncology Cell Therapies clinical operations financial planning/forecasting and budget management for assigned therapeutic area or therapeutic areas. Responsible for administrative budget oversight for direct and indirect reports.
• Represents Oncology Cell Therapies clinical operations as primary point of contact for therapeutic area, internal stakeholders and Strategic Partners and vendors.
• Responsible for leading the development of consistent Cell Therapies Clinical Operations processes and creating the support for unified approaches across therapeutic areas.
• Initiates, develops, leads and/or participates in global initiatives representing clinical operations in support of Takeda R&D objectives.

ACCOUNTABILITIES:

• Collaborates with Oncology and Cell Therapies global functional heads and TA leadership to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Responsible for on-time, on-budget delivery of oncology cellular therapy clinical trials.
• Ensures Oncology Cell Therapies clinical operations process and work product is compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
• Direct management of Cell Therapies clinical operations staff.
• Responsible for oversight of clinical budget planning/forecasting and management for cellular therapy programs.
• Oversees, reviews and approves operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modelling.
• Maintains current cell therapies landscape knowledge and continually assesses impact of new and evolving information on operational strategies.
• Escalates issues related to quality, timelines and budget and provides recommendations to upper management for resolution of these issues.
• Optimizes Cell Therapies clinical operations organization to impact speed, quality, and costs.
• Build highly effective external cell therapy network of contributing KOLs/PIs and clinical sites to deliver on plan.
• Contribute to the creation and maintenance of systems / processes for the purpose of reviewing and integrating data in real time, including assisting to identify key sources of cell therapy data (i.e., manufacturing, translational, etc.)
• Supports strategic outsourcing by participating in strategic vendor governance, including identification and resolution of performance issues.
• Leads and/or participates in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives.
• Responsible for functional leadership in Cell Therapies clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a matrix environment.
• Acts as a role model for Takeda´s values.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
• 15+ years’ experience in pharmaceutical industry and/or clinical research organization, including 10+ years clinical study/program management, including at least 6 years of line management experience. 5+ Years’ experience in Cell Therapies clinical operations. Recent Early Oncology experience preferred.
• Proven track record of leadership and project management success at the director level required.
• Expert knowledge of global regulatory and compliance requirements for cellular therapies clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
• Global/International cell therapy experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written).
• Experience in successful culture and change management (strategy, initiation, development and implementation of important, organization wide changes).
• Experience with independently mentoring, developing, and growing a team with very specialized skill set, preferably in hybrid/in-sourced operations model.
• Previous line management or direct management of team members.

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.

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

Base Salary Range: 194,000.00 to 278,000.00 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 & 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.

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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.

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