Michal Konstacky
Managing Director/Consultant
Experience
Mar 2023 - Present
2 years 5 monthsHorgen, Switzerland
Managing Director/Consultant
K Medical Consulting GmbH
- Consulted for AstraZeneca (Forxiga: chronic renal and heart failure, T2DM), Pfizer (ATTR cardiomyopathy registry), Merck (rare diseases, BD/due diligence), and Idorsia (daridorexant: insomnia PIP, cenerimode: SLE Phase II safety physician), PrimeVigilance (ovarian cancer).
- Reviewed EU scientific grants for the Czech Ministry of Education.
- Served as an evaluating committee member for the Czech Academy of Sciences.
- Acted as CMO in device and biotech startups (Sherpa Healthcare, HTG Medical, C-mo).
Jun 2021 - Feb 2023
1 year 9 monthsBasel, Switzerland
Senior Medical Director
Luzsana
- Led global Phase I-III clinical programs in diabetes, Alzheimer's disease, and eosinophilic esophagitis.
- Managed a cross-functional team of 60 across China, the US, and the EU.
- Delivered regulatory strategies and human factor studies for drug-device combination products.
Sep 2020 - May 2021
9 monthsBasel, Switzerland
Global Medical Director
Roche
- Oversaw early-stage clinical trials for Angelman syndrome and Dup15q syndrome (Phase IIa, Proof of Concept).
- Developed the medical section for the Briefing Book for the End-of-Phase I (EoPI) meeting with the FDA.
- Organized two advisory boards.
- Served as Governance Reform Squad Leader for pRED.
Sep 2019 - Aug 2020
1 yearZürich, Switzerland
Global Medical Director
Takeda
- Oversaw the SHP647 program for Crohn's disease and ulcerative colitis, under the supervision of the European Committee.
- Developed a Phase II program for primary sclerosing cholangitis (PSC).
- Led advisory boards and integrated patient input into the study design.
Sep 2018 - Jul 2019
11 monthsZürich, Switzerland
Senior Director
Aegerion
- Managed a 17-member team and led the EU launch of metreleptin for rare metabolic disorders.
- Developed medical information and pharmacovigilance infrastructure.
- Established a patient registry.
- Organized advisory boards and orchestrated three clinical trials in lipodystrophy.
Jun 2014 - Aug 2018
4 years 3 monthsZug, Switzerland
Global Medical Affairs Director
Shire
- Led programs for Hunter syndrome (MPS II) and other lysosomal storage disorders (MPS IIIa, MLD).
- Prepared regulatory submissions.
- Organized conferences and advisory boards and managed safety reporting, including the HOS registry.
- Directed the launch of the intrathecal program (Hunter IT).
Sep 2012 - May 2014
1 year 9 monthsZürich, Switzerland
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.
Apr 2010 - Aug 2012
2 years 5 monthsZürich, Switzerland
Head of Respiratory Medical
Nycomed
- Managed pre-launch and launch activities of the medical team for respiratory drugs, including roflumilast (COPD).
- Co-designed a €120M COPD mortality study.
- Collaborated with Orion Pharma (Finland).
Feb 2009 - Mar 2010
1 year 2 monthsBasel, Switzerland
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.
Sep 2007 - Jan 2009
1 year 5 monthsBarcelona, Spain
International Medical Manager
Almirall
- Led pre-launch activities for aclidinium bromide (COPD).
- Collaborated on human factor and lung deposition studies.
- Partnered with Forest Laboratories for co-development efforts.
Jan 2003 - Aug 2007
4 years 8 monthsPrague, Czech Republic
Medical & Safety Manager
AstraZeneca
- Oversaw cardiovascular, GI, and neuroscience portfolios, including major clinical trials and product launches.
- Supervised pharmacovigilance operations (PSURs, RMPs) and ensured compliance with EMA and FDA regulations.
- Supported the JUPITER trial (rosuvastatin) and MLR reviews as a nominated signatory.
Sep 1995 - Dec 2002
7 years 4 monthsHradec Kralove, Czech Republic
Assistant Professor
University Hospital
- Taught and mentored medical students and residents in internal medicine, sport medicine, and cardiology within the cardiometabolic department.
- Conducted research in cardiovascular diseases and supervised clinical trials as principal investigator.
- Provided advanced diagnostic and therapeutic services, including echocardiography and GI endoscopy.
- PhD theses focused on Helicobacter pylori inflammation and cardiovascular disorders.
Summary
Accomplished physician and global leader with over 20 years in the pharmaceutical industry and 12+ years in academia and clinical practice.
Expert in:
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.
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.
Languages
Czech
NativeGerman
NativeFrench
AdvancedItalian
AdvancedPolish
Advanced ...and 4 more
Education
Oct 2010 - Jun 2013
City University of Seattle
MBA · Business Administration · Seattle, United States
Oct 1999 - Jun 2002
Charles University in Prague / Aarhus University
PhD · Prague, Czech Republic
Oct 1989 - Jun 1995
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
Integrative psychotherapy lecturer
INCIP
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