Kristian Ewald
Head of Team Migraine Senior Indication Lead @Perfood
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WORK HISTORY
Head of Team Migraine Senior Indication Lead @Perfood
At Perfood, I lead the strategic development of our digital therapeutic, sinCephalea®, guiding it from clinical concept to regulatory success. I engage directly with international health authorities including BfArM, FDA, HAS including PECAN to shape the regulatory path, ensuring we meet the highest standards for digital health approvals. My role spans end-to-end oversight of clinical studies, building strong evidence for market access and payer dialogue. I’ve also cultivated key scientific relationships in neurology and pain medicine, which have been essential for expanding adoption and credibility. Leading expansion strategies into the US, Japan, and France has allowed me to bring our innovative solutions to new patients across the globe.
EDUCATION
Kiel University
Doctor of Medicine (Dr. med.), Medizin
Kiel University
Medical Degree (State Examination & Licensure – Approbation as Arzt), Humanmedizin
German Sport University, Cologne
A-Trainer License, Volleyball
FAU Erlangen-Nürnberg
Master of Health Business Administration
ABOUT KRISTIAN EWALD
Strategic Medical LeadershipI am a senior medical affairs executive with over a decade of experience shaping global medical strategies across pharmaceuticals, digital health, and medical devices. My expertise lies in bridging scientific excellence with strategic business goals, delivering regulatory success, clinical impact, and market access across Europe, North America, and Asia-Pacific.Clinical Development & Regulatory ExpertiseWith deep knowledge of clinical trial oversight, I’ve led complex programs from design to execution under ICH-GCP and EU-GVP standards. My work spans Phase I–IV trials, real-world evidence generation, and successful consultations with global regulatory bodies including BfArM, FDA, and HAS. I bring proven capabilities in accelerating approvals, aligning development with reimbursement, and driving cross-functional coordination.Pharmacovigilance & Risk ManagementAs a certified EU-QPPV, I have led global pharmacovigilance systems, integrating signal detection, risk mitigation, and regulatory compliance into company-wide safety cultures. I’ve overseen safety governance, PSUSA/PRAC procedures, and built robust QMS frameworks that improved audit outcomes and patient safety.Innovation in Digital HealthIn recent years, I’ve focused on digital therapeutics and health technology, leading the clinical and regulatory path for applications like sinCephalea®. I combine scientific rigor with digital innovation, ensuring regulatory acceptance, payer alignment, and adoption by healthcare professionals through KOL advocacy and clinical evidence.Leadership PhilosophyI lead by combining scientific insight with operational execution—building high-performance teams, mentoring future leaders, and fostering strategic partnerships with KOLs and regulatory authorities. My goal is to deliver impactful solutions that improve patient outcomes and advance healthcare innovation.
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