Responsible for clinical supply strategy, execution and program management for Takeda global clinical programs in assigned therapeutic area/areas, supporting clinical strategy defined in Global Development Plans
Responsible for Global Clinical Trial Supply Chain financial planning/forecasting and budget management for assigned therapeutic areas.Responsible for administrative budget oversight for direct and indirect reports.
Represents Global Clinical Trial Supply Chain at therapeutic area level as primary point of contact for Therapeutic Area Heads, internal stakeholders and vendors
Responsible for functional leadership for clinical supply program management, including hiring, training, staff assignments, coaching, mentoring, and performance management (including compliance) in a matrix environment.
Collaborates with key stakeholders in Development Operations and TAUs to define operational strategy for clinical supply support ofclinical programs, including risk management and contingency planning for supply activities.Responsible for on-time, on-budget delivery of clinical supplies in support of studies in assigned TAs.
Ensures clinical supply process and work product is compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU Directives, local country requirements and ICH GMP.
Direct management of Clinical Supply Program Managers including those with direct reports
Provides central point of contact for Global Clinical Trial Supply Chain to Therapeutic Area staff, Strategic Project Management, Therapeutic Areas Leads, CMSO Global Project Leaders and Finance for strategy, planning, issue management, and program execution information.
Responsible for global budget planning/forecasting and management for assigned therapeutic areas.
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.Represents Global Clinical Trial Supply Chain in cross-functional strategic initiatives/ forums.
Supports Global Clinical Trial Supply Chain strategic planning and vendor selection by defining the needs for key therapeutic areas and ensuring the varied needs of the portfolio are covered.
Leads Global Clinical Trial Supply Chain, or CMCC 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 supply program management, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical supply staff in a matrix environment.
Acts as a role model for Takeda s values
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Bachelors Degree or international equivalent required, Life Sciences preferred.Advanced degree highly desirable.
10+ years of pharmaceutical experience with at least 7 years experience in supply chain.Experience in more than one therapeutic area highly desired.
Expert knowledge of global regulatory and compliance requirements for clinical supplies, including but not limited to US CFR, EU Directives, local country requirements and GMP.
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).
Requires approximately 5-10% travel, including overnight and international travel to other Takeda sites, packaging vendors, and project related travel.
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