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Reporting to the Vice President, US Market Access, the Senior/Executive Director, Trade Relations & Patient Services is responsible for overseeing and leading the management of Shionogi trade partnerships and optimizing patient services to ensure the effective distribution and accessibility of our products. This role will be responsible for developing, enhancing, and implementing Shionogi’s strategic business opportunities with key trade partners, primarily drug wholesalers, specialty distributors, and specialty pharmacies.
The Senior Director, Patient Advocacy will be responsible for developing a patient advocacy engagement strategy to define our cross-functional approach to working within the current and future therapeutic portfolio of Shionogi, focused primarily, but not exclusively on Rare Disease. This work includes strategic oversight, coordination, and implementation of patient advocacy and engagement programs as well as research and insights-gathering to support scientific evidence and patient outcomes aligned with corporate and brand strategy. This leader will coordinate with all internal constituents to ensure a 360-degree level of engagement is achieved. From trial protocol design to patient access support, this...
The mission of the Director/Senior Director, US New Products is to help drive organic growth by providing commercial insights and strategic recommendations to product development teams and management committees that maximize asset value across the mid-to-late-stage pipeline portfolio and through LCM, as well as drive inorganic growth by delivering commercial assessments and strategic recommendations on business development opportunities.
Shionogi Inc. is the U.S. subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company with state-of-the-art research capabilities that has provided innovative medicines essential to people's health for over 145 years. In the US, Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas such as pain and anti-infectives.
Shionogi is growing and looking for an exceptional TA...
The Associate Director, Product and Corporate Communications will report to the Senior Director, Corporate Communications and will lead the development and implementation of integrated Product and Corporate Communications. The individual in this role must be highly collaborative, have experience in the biotech or pharmaceutical industry, have a strong desire to be part of a growth culture, and have proven ability to drive effective communications strategies and programs.
The KAM position is focused on establishing access and demand and access for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision makers, key stakeholders, and clinicians on the clinical benefits of the product and establishing and gaining formulary adoption within the institutional IV antibiotic space. The KAM will be responsible for formulary access and sales at the top institutions in the U.S.
KAMs are responsible for calling on a variety of targeted healthcare professionals within the institutional setting,...
This Regulatory Affairs CONTRACTOR will assist the department with completing regulatory correspondence and submissions; assemble IND and NDA submissions; perform Quality Control reviews of regulatory submissions; and support regulatory activities pertaining to clinical study teams.
The Manager, Government Operations, Alliance Project Management will report to the Senior Director, Government Operations, Alliance Project Management and will support program management activities related to Shionogi and Qpex’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a liaison with internal teams, government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. The Manager coordinates efforts of cross functional teams to successfully execute complex, multi-year agreements and foster strong business relationships. This role requires experience working on government-funded pharmaceutical programs,...
The Manager, Government Operations, Alliance Project Management will report to the Senior Director, Government Operations, Alliance Project Management and will support program management activities related to Shionogi and Qpex’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a liaison with internal teams, government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. The Manager coordinates efforts of cross functional teams to successfully execute complex, multi-year agreements and foster strong business relationships. This role requires experience working on government-funded pharmaceutical programs,...
The Senior Director, Government Operations, Alliance Project Management is responsible for overseeing program management activities related to Shionogi’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a key liaison with government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. As a strategic leader, the Senior Director guides cross functional teams to successfully execute complex, multi-year agreements and fosters strong business relationships. This role requires deep expertise in managing...
The Senior Director, Government Operations, Alliance Project Management is responsible for overseeing program management activities related to Shionogi’s US Government Contracts, including partnerships with agencies such as BARDA, NIH, and the Department of Defense (DOD). This role serves as a key liaison with government agencies, ensuring alignment on program deliverables, budgets, and compliance reporting. As a strategic leader, the Senior Director guides cross functional teams to successfully execute complex, multi-year agreements and fosters strong business relationships. This role requires deep expertise in managing...
The Director/Senior Director, Primary Market Research will support internal customers to identify market insights that effectively drive strategic decision-making and maximize the commercial potential of Shionogi portfolio. The incumbent is responsible for the design and execution of primary market research studies that assess market landscape, product performance and marketing and sales initiatives for both in-line and new products within covered therapeutic area. The current focus is across Infectious Diseases, including hospital anti-infectives and COVID-19.
The candidate must have...
The KAM position is focused on establishing access and demand and access for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision makers, key stakeholders, and clinicians on the clinical benefits of the product and establishing and gaining formulary adoption within the institutional IV antibiotic space. The KAM will be responsible for formulary access and sales at the top institutions in the U.S.
KAMs are responsible for calling on a variety of targeted healthcare professionals within the institutional setting,...
The Associate Director/Director, Regulatory Affairs - Global Development Products (Anti-Viral), provides essential support to the Executive Director in overseeing regulatory activities related to antiviral initiatives on a regional and/or global scale. This role involves assisting in the development and execution of regulatory strategies, regulatory submissions, and fostering collaboration with regional regulatory authorities. The Associate Director will work closely with cross-functional teams to integrate antiviral considerations into product development, manufacturing, and commercialization processes. This position plays a pivotal role in ensuring alignment with company goals, regional requirements, and...
The IT Security Analyst will be responsible for supporting IT security operations. The position will provide technical analysis, guidance and hands-on delivery in the planning, implementation, and ongoing operations of IT security solutions. Will participate in technical research and development to ensure there is continuing enhancement of security.
The Manager/Sr. Manager, Clinical Business Operations will be responsible for clinical outsourcing and relationship management activities including:
• Vendor selection (conducting Request for Proposal (RFPs) proposal review and analysis and budget negotiations, development and execution.)
• Contract management throughout life cycle of study, setting of standards, cost savings development/tracking and budget management in support of the clinical development programs.
• Assist with and provide support in developing effective clinical contractual agreements (such as Confidentiality agreements as...
Shionogi is committed to incorporating the patient’s experience for a specific disease-state into its development programs. The voice of the patient, as it relates to concepts that matter to patients who are seeking care for treatment of a given medical condition, should translate into endpoints in a clinical trial that are being measured for inclusion in the regulatory label. The Director | Senior Director of COA Strategy Development & Implementation will be responsible to ensure assets across the pipeline, including assets focused on rare diseases, have included the right COA instruments to support given patient-centered endpoints. The Food and Drug Administration (FDA) has stringent requirements for endpoints that are...
The Senior Manager, Regulatory Affairs - GDP - Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role involves actively contributing to the development and execution of regulatory strategies, regulatory submissions, and collaboration with regional regulatory authorities. While providing valuable support to higher-level management, the Senior Manager focuses on executing regulatory tasks, ensuring compliance, and facilitating cross-functional collaboration to achieve successful outcomes for our QOL initiatives.
The Medical Operational Excellence Lead is responsible for driving continuous improvement initiatives, ensuring high standards of operational performance, ensuring Medical Affairs strategic projects are coordinated and executed timely, and fostering a culture of excellence within medical and clinical operations. This role involves collaborating with cross-functional teams to streamline processes, enhance productivity, and implement best practices, particularly but not exclusively in the area of field medical excellence, medical insights process, medical education development, and adopting innovative approaches to enhance impact and create efficiencies.
The Meeting Planner works across all Shionogi US departments and has the responsibility of oversight, execution, and management of all Shionogi non-HCP, internal (onsite) and external (off-site) meeting planning activities.
This individual will bring subject matter meeting and event planning expertise to Shionogi US, with responsibilities including both individual management of events as well as management of vendors (when appropriate) to ensure seamless execution of larger events, managing each meeting’s budget, and executing each program on-time and within budget while ensuring events, meetings, and activities are compliant. This role requires significant...
The Director/Senior Director performs and oversees business-driven analyses that generate in-depth customer-focused insights and identifies key business opportunities aimed at maximizing the commercial potential of the Shionogi portfolio. This individual will drive critical business decisions and inform company strategy through insightful analysis and external/industry experience.
This role will lead and generate insights and analytics for the US launch brands and pipeline opportunities across the anti-infectives and anti-viral portfolio, including COVID-19.
The KAM position is focused on establishing access and demand for a novel hospital antibiotic product to hospitals and hospital systems within an assigned territory. This includes educating formulary decision makers, key stakeholders, and clinicians on the clinical benefits of the product and establishing and gaining formulary adoption within the institutional IV antibiotic space. The KAM will be responsible for formulary access and sales at the top institutions in the U.S.