Aramesh Saremi
San Diego,CA
Summary
Experienced Medical Director, offering global expertise in clinical trials and epidemiological research, in both industrial and academic settings, leveraging a strong “hands-on” experience in study design, protocol development, regulatory compliance, medical monitoring, project management, and analyzing and interpreting large-scale complex data sets such as RWD and RWE. Robust leadership acumen to build productive relationships with peers, and other stake holders in the scientific, medical, and clinical communities. Articulate communicator with a strong track record of high impact results, publications, and presentations at national and international conferences. Well-versed in Medical Affairs and Research and Developments.
Overview
24
24
years of professional experience
Work History
Executive Medical Director, Clinical Development,
Eli Lilly Pharmaceuticals
Indianapolis, IN, Remote in San Diego
06.2021 - 04.2023
- Lead efforts to design clinical studies (Phase 2 -4)
- Clinical protocol development
- Cross-Functional team leadership and collaboration
- Clinical data analysis and interpretation
- Global Regulatory interaction
- Served as application expert for troubleshooting, developing and designing compelling solutions to business problems
- Interviewed and observed clinical end users and business stakeholders to understand workflows, processes, business rules and systems in use
Clinical Development Medical Director
Intercept Pharmaceutials
San Diego, CA
11.2019 - 06.2021
- Medical oversight and monitoring for ongoing clinical trials
- Ensure appropriate scientific rigor in design, conduct, validity, and interpretation of clinical trial to support regulatory applications or business/marketing objectives
- Partner with Medical Affairs and Commercial on strategic planning, authoring, and review of regulatory and commercial documents, scientific data disclosures
- Maintain close collaboration and cooperation with clinical operations on implementation and execution of clinical studies
- Contribute and be responsible to development planning, authoring and review of manuscripts and other scientific data disclosures
- Contribute to departmental resource planning, budgeting and timeline setting to meet company needs
- · Provide oversight and coaching to more junior clinical research personnel
- · Lead early and late phase pediatric studies
- Verified effective, consistent communication between department heads, medical staff and governing boards through board meeting attendance and synchronization of interdepartmental functions
- Attended healthcare conferences to stay abreast of evolution of technology and implemented improvements in practice
- Supervised clinical staff, providing continuous professional development opportunities and training to maintain and strengthen competencies
Global Medical Affairs Data Analytics Lead/Medical
Sanofi Pharmaceuticals
Bridgewater, NJ
09.2016 - 11.2019
- Building clinical research infrastructure
- Identify and fill data gaps
- Provide strategic and medical insights in a cross-functional matrix environment, creating alignment across Medical Affairs, R&D, CROs Statistics & other functions
- Support development and strategic alignment of study protocols, Life Cycle Management plans and other key study documents
- Health authorities’ discussions and approval for label expansion
- Smart App development study for payers
- Payors Medical input value access group
- Establishing appropriate data mining and analytics process for submission and tracking, initiation, review and approval, and documentation of individual requests from global and affiliates
- Interpret scientific data
- Working in close collaboration with internal and external authors and publication steering committees
- Management and development of scientific publication’s platform and execution of primary and secondary publication plans
- · Responsible for ensuring accuracy and completeness of all data analysis, generating communications and reports
- · Support study execution teams for assigned trials to achieve efficient high-quality study as medical lead and medical monitor for global phase 3/4 clinical trials
- · Review and tracking of investigator-initiated proposals and other research grants
- Setting clear vision and strategic priorities for Real World Evidence
Health Research Scientist
Carl T. Hayden Veterans Affairs Medical Center
Phoenix, AZ
10.2016 - 11.2016
- Principal Investigator and Co-Investigator on a number of pilots, feasibility and large longitudinal multicenter studies
- Conception, design, and execution of clinical and epidemiological studies
- Data base management, compile, analyze, interpret scientific content of data using SAS statistical Software
- Promoting effective collaboration with other investigators and supporting ethical research activities
- ·Present study findings at international and local scientific meetings
- Publish in peer reviewed journals and generate preliminary data for future grants
Clinical Research Fellow
National Institutes Of Health/NIDDK
Phoenix, AZ
09.1999 - 09.2004
- Designed and implemented epidemiological clinical studies
- Attended research clinic and performed biennial physical exams for screening and prevention of type 2 diabetes and its complications
- Analyzed, interpreted large-scale complex data sets (Real World Data) from longitudinal biennial examination collected since 1965
- Protocol development
- Publications in peer reviewed high impact medical scientific journals
- Presented study findings at international and local scientific meetings
Education
Master of Science - Medicine
Ludwig Maximillian's University
Munich, Germany12.1991
Skills
- Author Reports
- Practice Management
- Protocol Development
- Medical Histories and Vital Statistics
- Operational Standards
- Clinical Instruction
- Recruit Well-Qualified Staff
- Patient Safety
- Clinical Study
- Articulate Communication
Timeline
Executive Medical Director, Clinical Development,
Eli Lilly Pharmaceuticals
06.2021 - 04.2023
Clinical Development Medical Director
Intercept Pharmaceutials
11.2019 - 06.2021
Health Research Scientist
Carl T. Hayden Veterans Affairs Medical Center
10.2016 - 11.2016
Global Medical Affairs Data Analytics Lead/Medical
Sanofi Pharmaceuticals
09.2016 - 11.2019
Clinical Research Fellow
National Institutes Of Health/NIDDK
09.1999 - 09.2004
Master of Science - Medicine
Ludwig Maximillian's University