Senior Director Clinical Operations, CAR-NK TAK-007
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Senior Director Clinical Operations, CAR-NK TAK-007Apply Now
The Clinical Operations Leader is fully-dedicated and responsible for the overarching CAR-NK platform and TAK-007 clinical operations strategy, its execution, and management of the clinical programs, supporting the clinical strategy as defined in the Clinical Development Plan (CDP). Key activities include strategy and planning towards milestones, managing the supporting clinical operations team, managing external vendors and critical path activities, proactively identifying issues, resolving conflicts, and communicating project-related challenges / issues to the Global Project Leader. Additionally, the TAK-007 Clinical Operations Leader will be responsible for financial planning / forecasting and budget management for the TAK-007 clinical operations strategy, as well as for administrative budget oversight for direct and indirect reports. The TAK-007 Clinical Operations Leader will represent Global Clinical Development Operations as the primary point of contact across the Global Project Team, the Oncology Therapeutic Area Unit, other internal stakeholders, and vendors. The Leader will work closely with key functions within the Global Project Team (e.g., Clinical, Translational, Biostats, Data Integration) and external vendors to ensure that project deliverables, timelines, and budget are met to maximize value and to realize Takeda’s overall vision. Furthermore, the TAK-007 Clinical Operations Leader will engage with the broader Clinical Development Operations community within Takeda and participate in global initiatives representing Clinical Development Operations in support of Takeda R&D objectives. This role will build and lead a team of clinal development functions initially including clinical trial manages, site engagement catalyst, data management and other roles to build capabilities for exceptional operational execution.
Reporting to the Global Project Leader, works collaboratively as a Core Global Team Member to partner with Global Clinical Lead and other key functions within the Global Project Team, including key internal stakeholders to define operational strategy for TAK-007, our first CAR-NK platform therapy.
Oversees and directs CRO deliverables as per the Global Development Strategy
Maintains responsibility for on-time, on-budget delivery of clinical development plan
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
Oversees clinical budget planning / forecasting and management for TAK-007
Directly manages clinical operations staff
Works closely with vendors and directly oversees critical path activities to ensure adherence to timelines
Proactively identifies project risks before they arise and develops contingency plans; escalates issues related to quality, timelines, and budget and provides recommendations to upper management for resolution
Optimizes our cell therapy Clinical Operations organization to impact speed, quality and costs.
Builds highly effective external cell therapy network of contributing sites to deliver on plan
Contributes to the creation and maintenance of systems / processes for the purpose of reviewing database progress in real time, ensuring timely resolution of outstanding queries and database cleaning, and applying data analytics to large data sets
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
Maintains current cell therapy landscape knowledge and continually assesses impact of new and evolving information on operational strategies
Maintains responsibility for functional leadership in global clinical operations for TAK-007, 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, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelors Degree or international equivalent
At least 15 years of clinical study / program management experience in the pharmaceutical industry, including at least 6 years of line management experience
Proven track record of leadership and project management success at the director level
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, 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
Bachelors Degree or international equivalent in the Life Sciences; advanced degree highly preferred
Experience in cell therapy and/or oncology highly preferred
Broad business orientation highly preferred
Experience with project leadership and management systems and methodology
Multi-faceted background with direct involvement or experience working with functions from multiple divisions
Must have an understanding of and experience with worldwide Regulatory submissions and approval processes
Expert knowledge in the overall pharmaceutical drug development process
Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions; negotiation and strong persuasive abilities
Strong written and verbal Communication Skills: ability to express oneself clearly and concisely to external partners, vendors or with others within the team; ability to message key issues appropriately and document issues and/or concerns concisely and comprehensively; ability to adjust language and/or terminology appropriate for the audience; demonstrated ability to clearly and concisely communicate / present key information to senior management
Analytical and Problem Solving Skills: ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Strategic Implementation: ability to develop, implement and monitor the overall clinical operations strategy
Leadership Skills: develops and uses knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takeda’s goals and objectives; requires the flexibility and tolerance to best manage change and differing opinions with diplomacy and competence
Ability to drive decision-making within a cross-functional, cross-divisional and cross-cultural, global team structure and requires global mindset and cultural awareness in working with senior leadership in other regions and in managing cross-regional projects
Knowledgeable in the processes for managing and developing personnel in a cross-functional, matrix-team, global environment with a proven track record
Knowledgeable in budget and finance processes appropriate to the pharmaceutical industry
Ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Ability to capture knowledge within the cross-functional, cross-divisional global organization; improve solutions, processes, and deliverables through use of information; improve information capital by contributing experience, theories, deliverables, and models for others to use
Management of multiple tasks of varied complexity simultaneously
Ability to work in a demanding environment with aggressive project timelines
Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required
Requires approximately 20-25% travel
Job ID R0023270