Sherly Mosessian
Chief Scientific Officer at SOFIE- Claim this Profile
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Bio
Experience
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SOFIE
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Chief Scientific Officer
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Apr 2022 - Present
As the Chief Scientific Officer, formulate the strategic plan for scientific objectives of the organization, including establishing the pan-tumor radiopharmaceutical diagnostic clinical development program. Direct all facets of clinical development efforts through FDA approval for SOFIE’s products. Oversee regulatory requirements, including Quality Assurance, and provide leadership in engagements with regulatory entities. Engage and as appropriate, lead interactions with external academic… Show more As the Chief Scientific Officer, formulate the strategic plan for scientific objectives of the organization, including establishing the pan-tumor radiopharmaceutical diagnostic clinical development program. Direct all facets of clinical development efforts through FDA approval for SOFIE’s products. Oversee regulatory requirements, including Quality Assurance, and provide leadership in engagements with regulatory entities. Engage and as appropriate, lead interactions with external academic, industry and contract research organizations (CRO), and establish collaborations consistent with internal strategies.
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Vice President Clinical & Regulatory Affairs
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Oct 2021 - Apr 2022
Provide clinical leadership to establish a pan-tumor radiopharmaceutical diagnostic clinical development program from inception to marketing approval. Develop and implement clinical strategies and be responsible for oversight of personnel and vendors in implementing various aspects of the clinical program. Serve as a liaison between SOFIE and investigators and establish a productive relationship with key stakeholders and regulatory entities.
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UCLA
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United States
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Higher Education
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700 & Above Employee
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Director of Research Enablement- DGIT, UCLA Health IT
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Dec 2018 - Oct 2021
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Chief Administrative Officer- DGIT, UCLA Health IT
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Nov 2015 - Oct 2021
University of California Los Angeles Under the direction of the David Geffen School of Medicine (DGSOM) Chief Information Officer (CIO), and as part of the Digital Technology (DGIT) team, the DGIT Chief Administrative Officer and Director of Research Enablement (CAO/DRE) is responsible for two distinct functions: (1) leading and collaborating with the DGSOM Dean’s office around the business administrative components DGIT, including oversight and development of IT governance, strategic supplier management, DGIT communication, IT… Show more Under the direction of the David Geffen School of Medicine (DGSOM) Chief Information Officer (CIO), and as part of the Digital Technology (DGIT) team, the DGIT Chief Administrative Officer and Director of Research Enablement (CAO/DRE) is responsible for two distinct functions: (1) leading and collaborating with the DGSOM Dean’s office around the business administrative components DGIT, including oversight and development of IT governance, strategic supplier management, DGIT communication, IT financial management, IT workforce management, and IT organizational design; and (2) leading the DGIT research enablement initiative, which oversees and harmonizes efforts to support research and faculty in areas such as onboarding, research computing, genomic analysis, inter and intra institutional collaboration, high performance computing, large data storage, and access to clinical data sets and analytic services. The CAO/DRE oversees new initiatives as needed, including managing the execution of select, high-impact, enterprise-wide strategic efforts, such as the DGIT deployment of UC OATS, or management of web development and web strategy. The CAO/DRE partners with the CIO to provide vision and direction for DGIT and the UCLA health-sciences schools IT enterprise, and acts as chief of staff for the CIO office, assuming CIO responsibilities as appropriate.
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Acting Chief Information Officer- DGIT, UCLA Health IT
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Dec 2018 - Mar 2020
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UCLA
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United States
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Higher Education
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700 & Above Employee
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Chief Administrative Officer, Department of Molecular and Medical Pharmacology
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Aug 2010 - Nov 2015
As the CAO I provide ongoing executive leadership to the Department of Molecular and Medical Pharmacology, which includes the Ahmanson Translational Imaging Division and the Crump Institute for Molecular Medicine. Total combined resources are currently estimated at $39,000,000 with a total of approximately 300 academic and staff employees. In my capacity as CAO, I provide ongoing executive leadership with responsibilities that include direct management of all administrative operations… Show more As the CAO I provide ongoing executive leadership to the Department of Molecular and Medical Pharmacology, which includes the Ahmanson Translational Imaging Division and the Crump Institute for Molecular Medicine. Total combined resources are currently estimated at $39,000,000 with a total of approximately 300 academic and staff employees. In my capacity as CAO, I provide ongoing executive leadership with responsibilities that include direct management of all administrative operations, including the centralized financial information system, facilities, human resources, information technology, intellectual property, graduate student support, and pre- and post-award services. I also administer the Nuclear Medicine clinic and oversees FDA regulatory matters involving the manufacturing and human administration of PET tracers and departmental representation to various local, state and national agencies. Develop and execute the goals aligned with the strategic plans for the department, division, and institute.
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Director of pre-clinical research
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Jan 2010 - Dec 2010
University of California Los Angeles The Pre-clinical Research Director is responsible for coordinating regulatory processes and procedures involving clinical trial initiation and approvals for Positron Emission Tomography imaging probes, as well as financial and grant management in the Ahmanson Biological Imaging Division/Nuclear Medicine Clinic in the Department of Molecular and Medical Pharmacology. Additional duties include coordinating renovations and building projects, overall coordination of the chemistry laboratory, and… Show more The Pre-clinical Research Director is responsible for coordinating regulatory processes and procedures involving clinical trial initiation and approvals for Positron Emission Tomography imaging probes, as well as financial and grant management in the Ahmanson Biological Imaging Division/Nuclear Medicine Clinic in the Department of Molecular and Medical Pharmacology. Additional duties include coordinating renovations and building projects, overall coordination of the chemistry laboratory, and establishing a workshop series with courses designed to address the needs and interests of the division. Reason for leaving: promotion
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Regulatory Affairs Specialist
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Nov 2012 - Oct 2015
Serving as a consultant to academic institution and biotechnology companies interested in obtaining regulatory approvals for PET radioparmaceuticals from the FDA and establishing PET cGMP compliant facilities.
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Trethera
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United States
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Pharmaceutical Manufacturing
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Chief Operating Officer
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Aug 2013 - Dec 2014
As the Interim COO was responsible for all aspects of operations management, including financial, SBIR submission, R&D planning and path to FDA approval for drugs in the pipeline of this newly founded biotechnology company. Served as the management liaison to the board and founders of the company on all operational matters.
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Graduate Student Researcher
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Jun 2004 - Nov 2009
A graduate student researcher in the department of Molecular and Medical Pharmacology at UCLA completed a dissertation research in the area of cancer biology.
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Education
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UCLA
PhD, Cancer Research -
University of California, Los Angeles
B.S, Biochemistry