Hardean E. Achneck
Clinical Development Executive | Founder-Operator & Company Creation | EIR, Yale Ventures | Most recently EVP/CMO, Aligos
- Role
- Entrepreneur in Residence (Eir) at Yale Ventures
- Location
- South San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Hardean E. Achneck
Physician–Scientist | Chief Medical Officer | EIR, Yale Ventures | Founder-Operator (Venture Creation)I’m a dual US/EU-licensed physician–scientist and public-company biotech executive with a track record driving clinical strategy, investor/board engagement, and contributing to major value-creating events. I have extensive experience leading global clinical programs from IND through Phase 3 and NDA. My focus has been in liver, fibrotic, and rare diseases, with additional experience in multiple other areas of high unmet medical need primarily across siRNA, small-molecule, and antibody platforms.Most recently, I served as EVP & Chief Medical Officer at Aligos Therapeutics. I’m currently an EIR at Yale Ventures, partnering in venture creation and evaluating translational opportunities. My focus is founder-aligned company building—advancing high-potential assets alongside founders and investors, from newco formation through clinical stage. I also take on select advisory and fractional CMO/interim clinical development engagements that align with this focus.Key areas of impact:• Advanced programs from preclinical to pivotal stages across liver diseases, infectious diseases, rare diseases, pulmonology, cardiovascular and metabolic diseases, oncology, and neurology.• Led global regulatory submissions and secured IND/CTA approvals in 15+ countries (North America, EU, Asia) and negotiated adaptive trial designs with FDA.• Helped secure $100M+ in PIPE financing from premier life sciences investment firms.• Contributed to major transactions, including the $1.67B+ out-licensing of xalnesiran to Roche and Dicerna’s $3.3B acquisition by Novo Nordisk.• Regularly engaged with Boards of Directors on development strategy, value creation, and corporate alignment.• Proven leadership in building and managing high-performing teams across clinical development and clinical operations, medical affairs, pharmacovigilance, data management and biostatistics, and clinical pharmacology—including hiring, mentoring, and developing talent across functions.Earlier in my career, I served as Assistant Professor of Surgery and Pathology at Duke University Medical Center and of Cardiovascular & Metabolic Disorders at Duke-National University of Singapore. Bilingual in English and German, I integrate a global perspective, scientific rigor, and agile execution into my leadership style.Experiences: Small Molecules, Antibodies, Cell Therapy, Stem Cells, Gene Therapy, siRNA, Oligonucleotides, ASOs, mRNA, DNA
Experience
Entrepreneur in Residence (Eir)
Jan 2026 — Present
Education
Harvard Business School
Executive Education, Program for Leadership Development
2020 — 2021
Yale School of Medicine
Doctor of Medicine (M.D.)
2000 — 2005
Yale University
Bachelor of Arts (B.A.), Molecular Biophysics and Biochemistry
1998 — 2000
Skills
- Cardiovascular Biology
- Medicine
- Microfluidics
- Technical Writing
- Clinical Trials
- Lifesciences
- Cardiovascular Disease
- German-English
- Commercialization
- Surgery
- Pharmaceutical Research
- Invention
- Mammalian Cell Culture
- University Teaching
- Venture Capital
- Cell Biology
- Medical Writing
- Grant Writing
- Biomedical Engineering
- Regenerative Medicine
- Protein Chemistry
- Patent Applications
- Product Design
- Translational Science
- Stem Cells
- Mentoring
- Career Development
- Patents
- Medical/Surgical
- Cell Therapy
- Clinical Development
- Cross-Functional Team Leadership
- Biomaterials
- Medical Technology
- Technological Innovation
- Adverse Event Reporting
- Translational Research
- Cardiovascular Devices
- Prescription Drugs
- Business Strategy
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