Director, Pharmaceutical Sciences Program Leadership

Objective / Purpose

• Engage others by inspiring commitment; collaborate through influencing relationships, mobilize high performance, anticipate group needs, and develop capabilities aligned to those needs; champion change and mentor junior staff across technical and Takeda competencies.

• Independently lead development of strategy and plans for multiple complex programs.
• Lead and influence functional/divisional strategy, operations, and innovation.
• Provide strategic scientific leadership and program management for multiple global CMC development teams.
• Identify, mitigate, and communicate project/program risks; advance not only led teams but others facing challenges.
• Serve as functional expert in divisional and cross-divisional initiatives.
• Represent CMC on cross-divisional governance/development teams; provide strategy and accountability for CMC deliverables.
• Provide scientific leadership and innovation in pharmaceutical R&D; build cross-functional/global teams.
• Mentor department members; act as an internal consultant to Pharmaceutical Sciences.
• Develop departmental capabilities by assessing the business and anticipating changes.
• Represent Pharmaceutical Sciences in cross-divisional/corporate/global initiatives; cultivate networks with affiliates/alliance partners.
• Inspire commitment via meetings, writing, and presentations; develop business cases that motivate action.
• Ensure state-of-the-art technical/scientific standards; identify/evaluate/ recommend/ negotiate novel solutions.
• Critically review external technical/scientific reports and coordinate Takeda-sponsored work.

• BS + 18 years; MS + 16 years;
  PhD + 10 years.
• Expert knowledge of pharmaceutical development (laboratory techniques, instrumentation, problem solving, process engineering/manufacturing development, and experimental statistics) and contributions to external industry/advocacy groups.
• Knowledge of allied fields (e.g., chemical/analytical/physical chemistry, pharmaceutics, QA and/or regulatory affairs); advanced DMPK, Pharmacology, and Toxicology.
• Extensive cGMP and ICH guideline knowledge; knowledge of regulations/compendial requirements and regulatory agency interactions.
• Experience with global regulatory submission requirements and processes.

• Leadership for complex multidisciplinary programs.
• Risk management (technical, budgetary, schedule) and CMC technology/trend gap identification.
• Clear communication to stakeholders; concise documentation; represent CMC viewpoint.
• Resource management (people, information, technologies, time, capital).