Associate Medical Director, Clinical Sciences
Vor 3 Tagen
The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with hematologic, immunologic, and other rare and complex diseases. There are two main drivers of innovation in the PDT R&D group:
- Translational / Pharmaceutical Sciences:This innovation engine practices rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield.It combines translational research with pharmaceutical sciences and device, and receives inputs from and into clinical research and manufacturing sciences.
- Precision Medicine / Integrated Care Solutions:This innovation engine focuses on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations.In the process, this engine drives innovation by practicing patient-centric R&D.
The Associate Medical Director leads and drives strategy for the overall regional or global clinical development in partnership with others, taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda PDT R&D BU pipeline and inline products. Works in a highly matrixed, GPT-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to provide an effective, common approach and partnership regionally and locally. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the assigned product in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences PDT R&D leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.
**Your Opportunity**:
**Clinical Development team participation and leadership**:
- Represents Clinical Development for a given product and/or indication, and may represent Clinical Medicine on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.
- Responsible for development team strategy and deliverables producing the development strategy, clinical development plan and cinical protocols.Recommends scope, complexity and size, and influence the budget of all aspects of a program.Ongoing work output will involve continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Recommends high impact regional and global decisions. Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.A significant error in judgment may result in loss of approvability and/or commercial viability of a product.
**Synopsis / Protocol Development, Study Execution, & Study Interpretation**:
- Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies.Serves as an advisor to assoc. med directors and clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies.Presents study conclusions to Management and determine how individual study results impact the overall product strategy
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
**Trial Medical Monitoring**:
- Makes decisions regarding study conduct related to scientific integrity.
**External Interactions**:
- Directs activities involved in interactions with regulatory authories/agencies and clinical development and key opinion leaders relevant to assigned products in PDT R&D. Provides leadership and expertise in these activities, and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
**Due Diligence, Business Development an
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