Manages various change/transformation and continuous improvement initiatives, including Operational Excellence. Supports implementation of strategy and innovative approaches to change and improve the business.
Lead all Patient Access and Value Team input within selected GPT's (Global Product Team) that develop and deliver an integrated market access strategy for all early asset and BD products based on understanding of the science and disease, patient and care giver needs, and the evolving payer landscape and evidence requirements
Leads Global RPM activities in predicting and planning solutions to achieve operational excellence; driving cross-functional teams to achieve clarity on issues, interfacing with senior management and supporting decision-making, while monitoring timelines and developing strategies to stay on schedule and navigating through the internal Regulatory and Global Program Team governance for projects.
Plans and leads Legal Department finance and budget processes, including coordination of annual plan and monthly accrual processes with Practice Group Leaders, General Counsel, and local and global finance departments, vendor management, e-billing strategy, and analysis and recommendations for cost-saving measures.
Working with Business Development (BD), Research & Development (R&D), Global Commercial, and US Business Units to define and evolve US Commercial strategy and disease areas of interest and identify the best commercial opportunities for the assigned GI Therapeutic Area (TA)
Millenium Pharmaceutical • IN and 1 other location
Develop and execute strategic and tactical account planning, such as uncovering needs, stakeholder / influence mapping, identifying / prioritizing business goals, helping define value propositions, delivering value propositions developed in collaboration with marketing and managed market teams, developing tactical plans, etc.
Lead the bottom-up aggregation of all category data to inform the top-down target setting process, reconciling "gaps" between the bottom-up and top-down targets. This will require identifying a pipeline of strategic category initiatives and opportunities with high potential returns (Savings / Productivity / Risk Management / Innovation) that will meet or exceed targets, using external supply market / business intelligence, the application of benchmarking methodologies and internal business partner knowledge
Lead domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with the Code of Federal Regulations, local regulations, ICH and Takeda policies and procedures. Assess impact of audit findings on subject safety, data integrity, and business operations. Audits conducted require advanced auditing skills and may include the technically complex assignments, including audits of potentially high risk studies/vendors.
Leads a multi-disciplinary, multi-regional, matrix team through complex decisions. This individual has the expertise for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned area in multiple regions.
Oversight of Transparency activities under Takeda Policies and Processes: Manages clinical trial transparency activities for all Takeda clinical trials to ensure activities are harmonized worldwide, and comply with all applicable laws, regulations, industry requirements, and Takeda transparency procedures and commitments.
Responsible for reviewing, analyzing and interpreting safety information from ongoing clinical and non-clinical studies, alongside the assessment of ensuing scientific and medical implications. Further, coordinating/leading recommendations derived from new safety data for developmental compounds and marketed drugs, ensuring the primacy of patient safety.
Ensuring the compliance activities related to PV inspection/audit readiness for Global PV, coordinating with the US, EU and Japan Compliance leads and partnering with QA to determine internal PV audit areas of focus.