Senior Manager, Imaging Job at Eisai
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job Summary
The incumbent will be responsible for the day to day management and oversight of imaging activities for trials within Eisai’s Oncology pipeline. Since many Oncology studies include imaging based endpoints, it is critical that these activities be closely managed to ensure that quality data is obtained. The candidate will be able to provide imaging support for all assigned studies and resources with limited oversight from study inception through to conclusion and if appropriate, NDA/MAA submission. This will include responsibility for ensuring adherence to imaging aspects of study protocols and Eisai processes, vendor oversight, management and allocation of all tumor assessment data cleaning activities, as well as oversight of the status of imaging deliverables relative to both study team and program level timelines. The Senior Manager will also collaborate with Imaging department members to create, coordinate, and deliver tumor assessment trainings for the organization as needed.
Essential Functions
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Oversight of imaging-related activities, including management of assigned imaging department personnel (contract or permanent) working on studies within Eisai Oncology
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Provide day to day guidance and coaching to direct reports providing performance feedback on a regular basis
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Support skills gaps and development of technical expertise within the group to align with Eisai Oncology and study team needs
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Oversight of BICR vendor activities including vendor selection and oversight, the review and approval of BICR study documents (transmittal forms, site imaging manuals, charters, communication plans, transfer plans, etc.), imaging data transfer exports, and data reconciliation efforts, in order to ensure the receipt of clean and accurate BICR data in accordance with the assessment criteria and study protocol
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With limited oversight, act as the primary imaging representative within the Eisai study team for assigned studies from protocol design through to study conclusion including contributions to CRF design, data cleaning, and QC resulting in clean tumor assessment data that support the needs of the studies assigned
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Work with department leadership to improve and enhance current practices through the proposal and implementation of new processes (e.g. tumor data cleaning, standard templates), development and delivery of department wide training, and the adaptation of new technologies and methods to support efficient tumor data cleaning
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Contribute to ongoing evaluations of current BICR vendors as well as prospective new vendors and participate in vendor audits and/or visits as needed to ensure the collection of accurate BICR tumor assessments within study budget expectations
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As needed, manage requests from senior management and other Oncology functional groups for ad-hoc tumor assessment data queries and metrics to support study decisions or data inquiries
Requirements
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Bachelor's Degree in related scientific discipline required. Master’s degree preferred
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Imaging Core Laboratory experience (working with or for a core lab) strongly preferred.
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Six (6) years of experience including working on clinical trials with imaging aspects required.
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Experienced with phase II/III oncology trials and subsequent regulatory submissions.
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Scientific background with understanding of clinical development and drug development process together with a broad understanding and experience of clinical operations, vendor management, and data management within clinical trials using medical imaging.
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Strong verbal, written and interpersonal communication skills, especially relationship management, with ability to give/receive feedback and build concensus effectively.
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Experience in working in a global environment and with virtual teams.
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Experience with implementing imaging aspects of clinical trials from protocol development to final analysis and clinical study report including regulatory submissions.
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Familiarity with oncology image-based tumor response criteria such as RECIST 1.1, iRECIST, RANO, and Cheson lymphoma criteria.
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Experience in oversight and management of BICR vendors to ensure successful conduct of the imaging aspects of clinical trials ensuring data integrity and quality.
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Ability to work autonomously with strong organizational prioritization and analytical skills.
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Motivated team mentality with the ability to enhance current processes and suggest new methods to improve the efficiency of the wider team.
<10% travel expected
100% remote or hybrid work schedule available
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Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
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