Open to opportunities

Michael Abram

@michaelabram

Message

VP of R&D and CSO with 20+ years translating science into regulatory-ready therapies and commercial-ready portfolios.

United States

Message

What I'm looking for

I’m looking to lead translational medicine and R&D strategy that bridges discovery to market, strengthening integrated evidence generation, regulatory submissions, and global partnerships while building milestone-driven, cross-functional teams.

I’m an R&D executive and drug developer with 20+ years driving therapeutic product portfolios from discovery research through regulatory approval and commercial launch across small molecules and biologics. I’ve contributed to 2 INDs, 7 NDAs, and 3 BLAs/EUAs, including multiple blockbuster therapies generating $10B+ in cumulative revenue, and I bring expertise in R&D strategy, translational medicine, and integrated development planning.

In recent leadership roles, I’ve been trusted to build milestone-driven global teams across R&D, CMC, Regulatory, Medical, and Commercial functions (10+ FTEs, 4 regions) with $9M+ in program-level P&L accountability. I’ve led regulatory and crisis responses—executing scientific and regulatory strategy across antivirals and mAbs/vaccines (7 NDAs, 3 BLAs/EUAs) and leading post-Phase 2b failure strategy that generated exploratory scientific data enabling an M&A exit within 9 months.

I also focus heavily on evidence generation and external partnerships that move programs forward—securing $1.052M through External Sponsored Research collaborations, forging 200+ KOL relationships, and advising on pipeline prioritization, portfolio strategy, competitive intelligence, and investor engagements. Today, I’m the Founder & Fractional VP, R&D at an independent advisory firm (Arctos BioPharma Solutions, LLC), partnering with C-suite leaders to diagnose development gaps and operationalize R&D roadmaps from pre-IND through NDA/BLA and market launch.

Experience

Work history, roles, and key accomplishments

Current

Founder & Fractional VP, R&D

Current

Arctos Biopharma Solutions

Jul 2025 - Present (1 year)

Founder and fractional VP of R&D providing interim executive leadership and strategic R&D support to biopharma clients. Delivers IND and Phase 3 readiness assessment support, translational strategy advisory, and clinical pharmacology report writing to de-risk programs and support investor readiness.

R&D Strategy Translational Medicine Pharmacology Reports Clinical to Market Roadmaps Strategic Advisory

Scientific Consultant, R&D

HilleVax

Dec 2024 - Sep 2025 (9 months)

Served as a strategic advisor to the executive team following workforce reduction, supporting scientific publications, M&A due diligence, and clinical asset/sample management. Directed disposition of 300,000+ clinical repository samples to optimize costs and co-developed manuscripts from post-hoc exploratory analyses.

Strategic Advisory Scientific Publications Cost Optimization Post Hoc Analyses Manuscript Development

Head of Translational Medicine

HilleVax

Nov 2022 - Dec 2024 (2 years 1 month)

Led integrated R&D strategy for HuNoV vaccine candidates, overseeing Phase 1–3 immunovirology biomarker strategies for bivalent (HIL-214) and hexavalent (HIL-216) programs. Directed evidence generation planning, crisis strategy for post-Phase 2b failure, Scientific Advisory Board governance, and external sponsored research framework development to support Go/No-Go decisions and investor communicat

Integrated Evidence Planning Translational Medicine Immunovirology Biomarkers Regulatory Interactions Investor Communications Scientific Advisory Boards Externally Sponsored Research Immune Bridging

Director, Translational Medicine

AstraZeneca

Dec 2018 - Nov 2022 (3 years 11 months)

Directed a translational sub-team and contributed to program development teams supporting RSV and SARS-CoV-2 nonclinical pharmacology, clinical immunology/virology biomarker strategies, and molecular epidemiology/surveillance. Advanced global regulatory submissions and licensure efforts for mAbs and vaccines and maintained multi-year budget/P&L accountability across international collaborations.

Translational Medicine Program Development Immunology Virology Resistance Biomarkers NGS Molecular Epidemiology Regulatory Strategy Budget Management

Senior Medical Scientist

Gilead Sciences

Nov 2016 - Nov 2018 (2 years)

Supported medical and commercial launch efforts for HIV treatment and prevention products, along with post-marketing support for HIV/HBV and HIV/HCV co-infection therapies. Expanded medical influence through KOL relationships and generated evidence via External Sponsored Research proposals to address medical information gaps.

Medical Affairs HIV Prevention KOL Management Externally Sponsored Research

Research Scientist, Clinical Virology

Gilead Sciences

Dec 2010 - Oct 2016 (5 years 10 months)

Led HIV clinical virology and IND-enabling research, including nonclinical pharmacology and biomarker strategies for HIV/HBV/HCV susceptibility and resistance. Managed regulatory submission workstreams supporting NDA/eCTD approvals and contributed to assay and mechanism-of-action research used to advance antiviral development.