Senior Director Clinical Operations- Cell Therapy
Takeda Global Research & Development Centre (Europe)
Job ID R0021592 Date posted 07/20/2020 Location Boston, Massachusetts
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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Director, Clinical Operations for Cell Therapies in our Cambridge, MA office.
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.
- Responsible for clinical operations strategy, execution and management of global clinical programs in assigned therapeutic area or disease pathway or therapeutic area(s) or disease pathway(s), supporting clinical strategy defined in the Clinical Development Plan (CDP)
- Responsible for Global 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 Global Clinical Operations as primary point of contact for therapeutic area, internal stakeholders and Strategic Partners and vendors.
- Responsible for leading the development of consistent 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.
- Collaborates with 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 clinical trials.
- Ensures 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 clinical operations staff.
- Responsible for oversight of clinical budget planning/forecasting and management for assigned therapeutic area.
- Oversees, reviews and approves operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modeling.
- Maintains current therapeutic area 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.
- 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 global 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, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelors Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
- At least 12 years clinical study/program management experience in the pharmaceutical industry, including at least 6 years of line management experience.
- Experience in more than one therapeutic area and a proven track record of leadership and project management success at the director level required.
- Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
- Global/International experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written).
- Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).
- Previous line management or direct management of team members. ·
- Experience within Cell and/or Gene Therapies preferred
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
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.Locations
Boston, MAWorker Type
Job ID R0021592
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