Eisai

Design, plan, and interpret PET imaging studies for neurology clinical programs, collaborating with vendors, data analysts, and key opinion leaders. | PhD in a relevant field with at least 5 years of industry or academic experience in PET neuroimaging, with expertise in study design, data interpretation, and collaboration. | 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. Eisai is searching for a creative, resourceful, integrative thinker with deep expertise in PET imaging within the neurology space to support clinical and translational research. As the Associate Director, Translational Imaging, Clinical Pharmacology & Translational Medicine, the focus will be primarily on PET imaging to design and plan clinical imaging studies for various neurology clinical programs and interact with imaging vendors, help manage imaging studies, participate in data analysis, modeling and presentation of results to International Project Teams. Stay abreast of the PET neuroimaging field in neuroscience and provide guidance for selection of methods of study design and analysis for PET tracers. Provide a global resource for education, preclinical and translational strategy and application of PET methodology. Interact with key opinion leaders and CROs for successful execution of translational PET imaging studies. Essential Functions Quantitate and interpret imaging data Support other Clinical imaging research activities including PET tracer identification, development and study utilization External collaboration with Key Opinion Leaders in neuroimaging Interact with Imaging CROs Regulatory interactions regarding PET imaging in clinical development Contribute to design, editing, writing and review of protocols and technical imaging documents (e.g., imaging review charters) Work with data scientists and statisticians on analysis plans involving imaging endpoints Requirements PhD in relevant field plus at least 5 years of industry or academic experience Expert ability to plan, optimize and conduct PET imaging studies Good knowledge of PET instrumentation and acquisition protocols Ability to quantitate and interpret PET imaging data Ability to support other imaging research activities Experience communicating results to the project team members Experience preparing reports and giving presentations internally and externally Experience working collaboratively with team members, global unit members; key opinion leaders and CROs. Proactive, self-motivated and independent working style. Used to work in a multidisciplinary team and understand the needs and goals of the broader organization #LI-CC Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Translational Imaging, Clinical Pharmacology & Translational Medicine is from :$169,400-$222,400 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter. 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: Right To Work E-Verify Participation

Design and execute North America Clinical Quality Assurance strategy including audits, inspection management, quality system oversight, and staff development. | Bachelor's degree with 12+ years clinical research/operations experience, 5+ years GCP auditing, substantial inspection management experience, knowledge of international regulatory standards, and ability to manage staff. | 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. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai’s Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions · Independently conduct audits · Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits · Facilitate Sponsor health authority inspections of global clinical facilities and study sites · Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs · Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. · May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements · Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. · 5+ years of experience in GCP auditing. · Substantial experience in inspection management. · Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. · Demonstrated ability to operate and influence decision-making processes · Effective communication skills · Successful track record of supervising employees and managing cross-cultural differences · Technical and administrative capabilities to independently carry out routine, complex and for-cause audits · Knowledge of data integrity controls and systems quality for clinical area · Strong analytical skills and report writing skills · Experience with GxP systems including computer system validation and associated regulations, recommended. · Ability to Travel (approximately 20%) · Candidates near Eisai’s NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://us.eisai.com/careers-at-eisai/benefits. Certain other benefits may be available for this position, please discuss any questions with your recruiter. 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: Right To Work E-Verify Participation