Michal Konstacky - Managing Director/Consultant

Recommended expert

Horgen, Switzerland

Experience

Mar 2023 - Present

2 years 11 months

Switzerland

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)

Jun 2021 - Feb 2023

1 year 9 months

Basel, Switzerland

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

Sep 2020 - May 2021

9 months

Basel, Switzerland

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

Sep 2019 - Aug 2020

1 year

Zürich, Switzerland

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

Sep 2018 - Jul 2019

11 months

Zürich, Switzerland

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

Jun 2014 - Aug 2018

4 years 3 months

Zug, 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 advisory boards
Managed safety reporting, including the HOS registry
Directed the launch of the intrathecal program (Hunter IT)

Sep 2012 - May 2014

1 year 9 months

Zürich, 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 months

Zürich, 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 €120 M COPD mortality study
Collaborated with Orion Pharma (Finland)

Feb 2009 - Mar 2010

1 year 2 months

Basel, 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 months

Barcelona, Spain

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

Jan 2003 - Aug 2007

4 years 8 months

Prague, Czech Republic

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

Sep 1995 - Dec 2002

7 years 4 months

Hradec Kralove, Czech Republic

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

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

Czech

Advanced

English

Advanced

Polish

Advanced

Russian

Advanced

Slovak

Advanced

...and 4 more

Education

Oct 2010 - Jun 2013

City University of Seattle

Master of Business Administration · Business Administration · Seattle, United States

Oct 1999 - Jun 2002

Charles University in Prague / Aarhus Uni, Denmark

PhD · Aarhus, Denmark

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

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Experience

Managing Director/Consultant

K Medical Consulting GmbH

Senior Medical Director

Luzsana

Global Medical Director

Roche

Global Medical Director

Takeda

Senior Director

Aegerion

Global Medical Affairs Director

Shire

EMEA Medical Head

Aerocrine

Head of Respiratory Medical

Nycomed

International Medical Affairs Director

Solvay

International Medical Manager

Almirall

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AstraZeneca

Assistant Professor

Uni Hospital Hradec Kralove

Summary

Skills

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

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