Michal Konstacky
Managing Director/Consultant
Experience
Managing Director/Consultant
K Medical Consulting GmbH
- Consulted for AstraZeneca (Forxiga: chronic renal & heart failure, T2DM)
- Consulted for Pfizer (ATTR cardiomyopathy registry)
- Consulted for Merck (rare diseases, BD/due diligence)
- Consulted for Idorsia (daridorexant: insomnia PIP, cenerimode: SLE safety physician)
- Consulted for PrimeVigilance (ovarian cancer)
- Reviewed EU scientific grants for the Czech Ministry of Education
- Member of the evaluating committee for the Czech Academy of Sciences
- Served as CMO in device & biotech startups (Sherpa Healthcare, HTG Medical, C-mo)
Senior Medical Director
Luzsana
- Led global Phase I–III clinical programs in diabetes, Alzheimer’s, and eosinophilic esophagitis
- Managed a cross-functional team of 60 across China, the US, and EU
- Delivered regulatory strategies and human factor studies for drug-device combination products
Global Medical Director
Roche
- Oversaw early-stage clinical trials for Angelman syndrome and Dup15q syndrome (Phase IIa, proof of concept)
- Led development of the medical section for the End-of-Phase I briefing book for FDA Project Management meeting
- Organized two advisory boards
- Served as Governance Reform Squad Leader for pRED
Global Medical Director
Takeda
- Oversaw the SHP647 program for Crohn’s disease and ulcerative colitis under supervision of the European Committee
- Developed a Phase II program in primary sclerosing cholangitis (PSC)
- Orchestrated publications in leading journals (e.g., Lancet, NEJM)
- Chaired advisory boards and integrated patient input into study design
- Managed global drug and device launches
Senior Director
Aegerion
- Led cross-functional teams of up to 60 in multinational settings
- Managed a 17-member EU patient advocacy team
- Led the EU launch of metreleptin for rare metabolic disorders
- Developed medical information and pharmacovigilance infrastructure
- Established a patient registry
- Organized advisory boards
- Orchestrated three clinical trials in lipodystrophy
Global Medical Affairs Director
Shire
- Led programs for Hunter syndrome (MPS II) and other lysosomal storage disorders (MPS IIIa, MLD)
- Prepared regulatory submissions
- Organized advisory boards
- Managed safety reporting, including the HOS registry
- Directed the launch of the intrathecal program (Hunter IT)
EMEA Medical Head
Aerocrine
- Launched FeNO devices for asthma diagnostics
- Negotiated with payors and regulators
- Built and trained medical teams in Europe, China, and Japan
Head of Respiratory Medical
Nycomed
- Managed pre-launch and launch activities of the medical team for respiratory drugs including roflumilast (COPD)
- Co-designed a €120 M COPD mortality study
- Collaborated with Orion Pharma (Finland)
International Medical Affairs Director
Solvay
- Developed global KOL strategies across therapy areas
- Co-chaired the OSCAR cardiometabolic trial publication board
- Coordinated the Metabolic Syndrome Institute, a collaborative project with the Joslin Diabetes Center at Harvard
International Medical Manager
Almirall
- Led pre-launch activities for aclidinium bromide in COPD
- Collaborated on human factor and lung deposition studies
- Partnered with Forest Laboratories for co-development efforts
Medical & Safety Manager
AstraZeneca
- Oversaw cardiovascular, GI, and neuroscience portfolios, including major clinical trials and product launches
- Supervised pharmacovigilance operations (PSURs, RMPs)
- Ensured compliance with EMA and FDA regulations
- Supported the JUPITER trial (rosuvastatin) and MLR reviews as a nominated signatory
Assistant Professor
Uni Hospital Hradec Kralove
- Taught and mentored medical students and residents in internal medicine, sport medicine, and cardiology
- Conducted research in cardiovascular diseases and supervised clinical trials as principal investigator
- Provided advanced diagnostic and therapeutic services, including echocardiography and GI endoscopy
- Supervised PhD theses on Helicobacter pylori inflammation and cardiovascular disorders
Industry Experience
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Experienced in Pharmaceutical, Healthcare, and Biotechnology.
Business Area Experience
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Experienced in Research and Development, Product Development, Project Management, Quality Assurance, Strategy, and Human Resources.
Summary
Accomplished physician and global leader with over 20 years in the pharmaceutical industry and 12+ years in academia and clinical practice.
Proven ability to lead large, diverse teams and align global strategies with local requirements.
Key therapeutic areas: Neurosciences, rare diseases, cardiometabolic, GI, immunology, and respiratory medicine.
Skills
- Medical Affairs: Driving Successful Product Launches Across Multiple Therapeutic Areas.
- Clinical Development: Designing And Executing Early- And Late-stage Trials, Leading Regulatory Submissions (Nda, Bla, Maa).
- Pharmacovigilance: Ensuring Compliance, Risk Management, And Patient Safety.
Languages
Education
City University of Seattle
Master of Business Administration · Business Administration · Seattle, United States
Charles University in Prague / Aarhus Uni, Denmark
PhD · Aarhus, Denmark
Charles University in Prague
Doctor of Medicine · Medicine · Prague, Czech Republic · summa cum laude
Certifications & licenses
AI In Healthcare
MIT
Negotiation Mastery
Harvard
Internal Medicine Board Certified
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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