+10 years of experience in leading positions within clinical development & medical affairs
Certified nephrologist with vast experience in the medical & clinical development field (e.g. currently as Medical Director Clinical Development (Chronic Kidney Disease))
Strong expertise in the clinical research as well as the management of clinical trials (incl. planning, executing, reporting and publishing of result)
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- MD & PhD in Nephrology, Diabetology and Endocrinology (2012)
- Language Skills
- German (native), English (business fluent), French (business fluent)
- Relevant Expertise
- Nephrologist, Medical Director, Clinical Research, Clinical Development, Clinical Trial Management, GCP, Ph
Key-Facts
Extract from previous activities
Pharmaceutical Company, Switzerland
Interim Medical Director Clinical Development (Chronic Kidney Disease)
Responsible for preclinical and clinical development & support in product development
Planning and implementing of preclinical and clinical development plans
Providing medical input to Clinical Development Plan, Integrated Development Plan, Clinical Trial Protocols
Execution of clinical trials and management of CROs
Clinical protocol review
Strong cooperation with KOLs and Regulatory Authorities
Training of KOLs
Pharmaceutical Company, Switzerland
Interim Head of Clinical & Medical Group (Nephrology)
Conduction of registrational studies & trial studies
Strategic planning of global clinical programs and products launches
Execution of clinical programs & trials
Medical oversight and management during conduct of global clinical studies/programs
Management of medical information for Europe
Providence of medical & scientifical insights
Training and management of affiliate staff managers, external KOLs
Pharmaceutical Company, Switzerland
Interim Medical and Scientific Director
Medical & scientific representative
Leadership for phase I and III studies and supervision of CROs
Support of Regulatory as medical expert in the communication with FDA for clinical trials design and submissions
Management of relevant regulatory documents