US-MA, Medical Director, GI (USBU) R0008208-MZ
OBJECTIVE: The Medical Director will provide near and long term strategic direction as well as development and oversight of the scientific platform in support of the product strategies for assigned compounds within a specific therapeutic area. ACCOUNTABILITIES: Lead and direct relevant medical responsibilities by providing scientific insight and development of strategy for assigned compounds by participating and leading committees to realize Takeda s overall vision. Committees may include: Functional Planning Teams (FPT's), Commercial Planning Teams (CPT's) Product Strategy Teams (PST's), various development committees, Medical-Regulatory-Legal (MRL) Teams, ISR Committees, etc. and other teams as designated or as the compounds evolve and progress in development. Interact internally with senior level TPNA, TPC and TGRD management; advise and negotiate, as required, to guide the overall activities of the specific compound(s) and therapeutic area. Develop and maintain relationships externally through Advisory Boards, Professional Associations, Professional Meetings and Conferences, etc. to achieve Takeda s scientific objectives. Manage the budget for the specific Cost Center and provide direction and oversight for the overall therapeutic area budget. Provide medical direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, Supplemental NDA s, etc) Either directly, or indirectly through supervision, oversee the medical review and sign off of promotional pieces in support of the Medical-Regulatory-Legal committee for products within the specific therapeutic area(s). Participate in the publications strategy for assigned compounds by providing scientific and publication planning input. Provide input to confidential New Business Development opportunities within the respective therapeutic area of expertise, as required. Provide support for departmental initiatives that further our business, and support other departments within Takeda such as New Product Planning, Government Affairs, SPP (TPC), and some TGRD related projects, etc. Other medical and scientific support duties as assigned. EDUCATION, EXPERIENCE AND SKILLS: Required: * MD degree with at least 7 years of relevant clinical practice, research, academic and/or pharmaceutical industry experience. * Experience with clinical research, publication activities, congress presentations, and public speaking. Desired: * Board certification in therapeutic area related to the position. * Life cycle management experience. LICENSES/CERTIFICATIONS: Maintain minimum standards of education/certification in individual professional discipline PHYSICAL DEMANDS: TRAVEL REQUIREMENTS: ADDITIONAL INFORMATION: Knowledge * Industry Knowledge understands pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process. * Product Knowledge understands medical/therapeutic impact of products; understanding of potential product applications. * Takeda Operations Able to understand Takeda s operating structure and methods including a thorough knowledge of the foreign-owned parent company. Skills * Leadership demonstrable ability to provide ongoing feedback and coaching to employees and to guide other leaders within the department in doing the same. * Leadership demonstrable ability to use confidence, decisiveness and a willingness to listen to, influence and engage others in the accomplishment of functional goals. * Budget Management - demonstrable ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel * Communication ability to articulately communicate ideas and data both orally and in writing. Communications must be in a highly professional, persuasive and appropriate manner. * Analytical Skills ability to analyze a wide variety of scientific data including financial figures and market research data to make professional management decisions. * Business Process Acumen - ability to apply the knowledge of Takeda s core business capabilities to help the organization meet its goals and desired outcomes. * Strategic Approach ability to predict broad-based changes in business partner environment and translate them into functional strategies to continually meet business partner needs. * Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use. * Knowledge Management ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution. * Pharmaceutical Industry Acumen - ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry.
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