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Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. + Degree in Life Sciences (MD, PhD with 0-2 years of prior clinical research experience, or PharmD, MS, RN or other scientific degrees with at least 2 years of clinical research experience preferred.
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Prepares medical considerations sections for proposals Supports or participates in bid defense meetings Meets with clients as needed Write or edit scientific content of deliverables within budget timelines Collaborates with Regulatory Affairs on regulatory product landscape and strategies as a part of overall drug development strategy.
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Work closely with other functional teams, Upstream Process Development, Downstream purification, Analytical Development to support development activities. This organization is co-located with Upstream and Downstream Process Development, Process Analytics, and Analytical Development in New Brunswick and Summit sites in New Jersey.
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Engages as a matrix team member on protocol teams as a scientific partner in the drug development process. The Associate Director, Biostatistics is a core member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications.
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The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program.
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Responsible for representing GRA in the GPT (Global Project Team) as well representing the project team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Experience in providing regulatory strategic input into the Oncology drug development preferred.
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Support and provide commercial input/needs to the annual clinical development plan process providing strategy, forecast, commercial valuation and viability to support decisions. The Director, Global Oncology Marketing (Brand) is responsible for maximizing the commercial value of a specific indication(s) and/or tumor type(s) under the direction of the Global Brand Lead. Responsible for actively contributing to the development of the global brand strategy and for leading the development and execution of the tactical plan in support of the global brand strategy.
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Experience in providing regulatory strategic input into the drug development process with thorough knowledge of the IND and NDA/BLA processes. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
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Project management and coordination of PrM sub-team activities and regulatory submission deliverables, PrM regulatory documentation management, liaison with internal and external partners and provide project management and technically-associated logistic support for clinical bioanalysis and biomarker tasks, identify scientific operation improvement opportunities and drive cross-functional process improvement initiatives.
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Our ideal partner is a deep and dynamic thinker who can read beyond the data to create focused scientific concepts, push past observations to insights, and help guide our teams forward in strategic development.
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Develop statistical tools to streamline process development, QC testing and troubleshooting. Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Qualifications Must have comprehensive knowledge of applied statistical principles and modeling in drug research and development, and proficiency in statistical software such as SAS and R. Must have excellent interpersonal and effective verbal and written communication skills.
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In-depth knowledge of the Drug Development process, Signal Detection, and Regulatory Affairs. Profound knowledge of Scientific, Medical, and Clinical Research terminology, such as MedDRA coding.
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