Michal Konstacky

Managing Director/Consultant

Horgen, Switzerland

Experience

Mar 2023 - Present
2 years 5 months
Horgen, 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 months
Basel, 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 months
Basel, 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 year
Zürich, 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 months
Zürich, 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 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 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 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 €120M 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 (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) 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 months
Hradec 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
Native
German
Native
French
Advanced
Italian
Advanced
Polish
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

Need a freelancer? Find your match in seconds.
Try FRATCH GPT
More actions