US-MA, Global Clinical Development Lead SR0028836-MZ
Responsibilities Collaborates with Global Development Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within Takeda R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific and clinical development expertise and providing guidance in support of brands and product launches. Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams. Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings. Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles. May supervises a variable number of CD professional and administrative staff;; Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems. Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities. Provides expert scientific clinical development advice leadership to the project teams for the development of Phase I-IV clinical programs. Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy. Participates in drug safety surveillance for Development projects. Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions. Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders. Education & Experience Requirements MD is required. Three to five years experience in clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization. Demonstrated ability to collaborate in a matrix environment Experience with interactions with Regulatory authorities. Experience in designing and conducting Phase II-III clinical trials. Key Skills and Competencies Expertise in hematology and hemophilia management is preferred Experience in rare diseases highly desired Demonstrated in-depth understanding of drug development and pharmaceutical marketing within Therapeutic area. Working knowledge of regulations relating to drug development and promotional activities Demonstrated ability to communicate and plan effectively with other Takeda departments and to respond to inquiries or complaints from customers. Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences. Strong management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals skills, talents and career interests which ensure development of a talent pool for the future. Ability to create and maintain and organizational structure that serves the needs of the business. Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Takeda; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results. Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization. Strong business acumen preferred with the ability to shape corporate strategy using knowledge of the global pharmaceutical industry. Ability to capitalize on business opportunities by developing well thought out strategies and initiatives. Other Requirements Availability to travel approximately 25% of time. Availability to participate in early or late meetings/teleconferences.
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