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10.0 - 14.0 years

0 Lacs

hyderabad, telangana

On-site

The increasing demand for observational research (now commonly referred to as real-world evidence [RWE]) from regulatory and reimbursement authorities has made observational research a crucial component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with industry-leading analytical capabilities that generate RWE to support business needs across a product's lifecycle. CfOR scientists collaborate with internal stakeholders and industry experts to design, conduct, interpret, and publish observational research that informs decision-making at various stages from molecule development to clinical trial design and the safety and efficacy of Amgen medicines. We are looking for a dynamic, adaptable, and tech-savvy Strategic Planning & Operations Manager to oversee and drive the execution of CfOR's operational projects and non-interventional studies, ensuring timely completion within budget and at the highest quality. This role necessitates strong project management capabilities, a growth mindset, and a willingness to leverage emerging AI tools to enhance productivity and drive CfOR-wide initiatives. Key responsibilities include: - Developing collaborative relationships with stakeholders across CfOR and Amgen to ensure alignment with strategic objectives and operational priorities. - Leading the planning, coordination, and execution of projects using Agile methodologies, maintaining detailed project plans, facilitating meetings, and tracking milestones. - Providing ongoing support for headcount management, requisition tracking, staffing analysis, and organizational planning in line with CfOR leadership goals. - Driving the adoption and integration of platforms like Smartsheet, Microsoft Teams, and Miro to improve team collaboration and project tracking. - Leading or supporting strategic initiatives and operational pilots that enhance CfOR's organizational capabilities. - Communicating status and issues effectively to relevant parties within CfOR and across Amgen. - Supporting the Operations Head, leading special projects, conducting necessary analysis, and creating deliverables as required. - Identifying and implementing improvements to operational processes using AI tools and technology to increase team efficiency and reduce manual tasks. - Leveraging productivity and generative AI tools such as Microsoft Copilot, ChatGPT, and AI agents to streamline workflows, documentation, meeting summaries, data analysis, and communications. Basic Qualifications: - Doctorate degree with 2 years of research and program management experience OR - Masters degree with 6 years of research and program management experience OR - Bachelors degree with 8 years of related experience OR - Associate degree with 10 years of related experience OR - High school diploma / GED with 12 years of related experience Preferred Qualifications include: - Minimum of 10 years of project management experience, with at least 5 years in pharma/biotech within regulated, cross-functional environments. - Proven ability to lead complex projects end-to-end in fast-paced settings, including budgeting, resource planning, vendor management, and risk mitigation. - Skilled at managing ambiguity and shifting priorities through structured thinking, stakeholder alignment, and agile decision-making. - Highly motivated professional who excels with minimal supervision, balancing multiple initiatives while ensuring compliance with regulatory standards and organizational processes. - Expertise in evaluating current-state operations and designing scalable solutions to improve efficiency, quality, and stakeholder satisfaction. - Superior communication and presentation skills, with the ability to translate complex data into dashboards for diverse stakeholders. - Experience with Agile frameworks (SAFe highly preferred), Scrum, and Kanban, focusing on digital transformation and operational efficiency. - Comprehensive understanding of Good Clinical Practices (GCP), FDA regulations, and applicable regulatory/compliance frameworks relevant to clinical and commercial operations. - Proficiency in Smartsheet, Microsoft O365, and Miro, with a focus on utilizing tools for planning, tracking, and visual collaboration. - Passionate about continuous improvement and applying emerging technologies to enhance productivity and stakeholder engagement. - Working knowledge of AI tools like Microsoft Copilot, ChatGPT, and AI Agents, with practical experience integrating these into project workflows.,

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