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Simeon Berman

@simeonberman

Medical Affairs Director at FIRST MOUNTAIN MEDICAL STRATEGIES, advancing clinical programs and developing an FDA pathway prediction model.

United States

Message

At FIRST MOUNTAIN MEDICAL STRATEGIES, I direct Medical Affairs, medical education, and MLR/PRC governance for organizations including UCB, J&J, BD, Novartis, and Pfizer. I’m developing a proprietary AI Regulatory Behavioral Intelligence Model to predict FDA approval pathways.

At UCB / ENGAGE THERAPEUTICS, I directed Medical Affairs strategy for Staccato Alprazolam and helped advance the acquisition of Engage Therapeutics. I also tripled epilepsy trial site selection efficiency and saved $2.5M through predictive modeling and clinical trial optimization.

Experience

Work history, roles, and key accomplishments

Current

Co-Founder & Medical Director

Current

Cohesive Resources

Jan 2021 - Present (5 years 9 months)

Built middle-market healthcare alliance platform linking vendor partners to hospitals and health systems. Applied business acumen and budget management to structure cross-vendor value propositions.

Business Acumen Budget Management Vendor Management Healthcare Partnerships Digital Technologies AI Regulatory Compliance

Current

Medical Director

Current

First Mountain Medical Strategies

Jan 2004 - Present (22 years 9 months)

Directs strategic Medical Affairs, medical education, MLR/PRC governance, and process improvement initiatives for multiple pharmaceutical and medical device companies. Drives business development, M&A partnerships, and alliance strategies.

Medical Affairs Medical Education MLR PRC Process Improvement Business Development M&A Alliances Regulatory Strategy AI EMR Integration Digital Pathology

Distinguished Medical Expert AI Tutor

Meta AI Crosswinds

Jan 2025 - Dec 2026 (1 year 11 months)

Selected as one of 140 physician knowledge experts to develop and tutor Meta's advanced medical AI LLM. Led cross-functional team evaluating bioinformatics AI models for oncology therapeutics and US registries.

AI LLM Bioinformatics Oncology Data Integrity Clinical Assessment Medical Education Regulatory Compliance

Medical Director

Takeda / Point B Consulting

Jan 2023 - Dec 2024 (1 year 11 months)

Drove global clinical programs optimization, projecting 15-25% reduction in trial duration via AI dashboards and PI engagement. Pioneered 'Hub and Spoke' clinical trial network models and established KPI tracking metrics.

Clinical Trials Optimization AI KPI Tracking PI Engagement Medical Education HEOR Patient Advocacy

Medical Director, Alliance & Partnership Management

UCB / Engage Therapeutics

Jan 2018 - Dec 2021 (3 years 11 months)

Directed global clinical programs and medical affairs strategy for neuroscience/epilepsy asset Staccato Alprazolam. Managed multi-million-dollar budget and KPI tracking, tripling trial site selection efficiency and saving $2.5M.

Clinical Programs Medical Affairs Budget Management KPI Tracking Risk Based Monitoring Medical Content Solar PV Regulatory

Medical Director, Business Consulting & Program Development

The Medical Strategy Group / Meducation International

Jan 1998 - Dec 2004 (6 years 11 months)

Published and edited physician compendia for Novartis and Pfizer. Directed U.S. Navy corpsman medical education digitization and pioneered AI-assisted diagnostic software.

Medical Education Publishing AI Diagnostic software Clinical Trials Medical Devices Enterprise Systems

Senior Management Engineer

Lederle Laboratories

Led FDA Trivalent Polio Vaccine submission and designed the second U.S. fully automated pharmaceutical warehouse. Developed EPA consent decree compliance plans.

FDA Submissions Vaccine Development Warehouse Automation EPA Compliance HEOR

Associate Director of Proposal Review

Pennsylvania Department of Health Corp

Spearheaded post-disaster healthcare transformation, consolidating 7 regional hospitals into 3 medical centers. Managed bond-floatation analysis, merger negotiations, and strategic planning.

Healthcare Transformation Hospital Acquisitions M&A Negotiation Strategic Planning Fixed Income Analysis