10/28/2026 updated
TB
100 % available
Consultant Medical Affairs, Pharmacovigilanz, Clinical Development, Medical Device, Interim CMO
Jachymov, Czech Republic
Worldwide
BiopharmaceuticalsCertified Medical InvestigatorClinical TrialsDrug DiscoveryPharmacovigilanceMedical WritingPharmaceutical DevelopmentMalaria (Professional Expertise)
O Academic background in German law and Medicine with substantial pharmaceutical industry experience since 1998.
- Since 1999 experience in Drug Development and an active involvement in biopharmaceuticals compound conduct.
- Since 1998 research activities in Immunomodulation, Immunotolerance (Development of research programs, pre-clinical research (development of animal models, animal studies), clinical research (medical advice and development of CTPs and clinical reports) and academic research (medical advice and lap studies (e.g. immunotolerance) in T-cell reactions (e.g. gamma/delta cells – ) in the following indications: Cancer indications (MBC, CRC, NSCLC, MM), Osteoarthritis, Immunodeficiency Syndrome, SLE, Multiple Sclerosis, Malaria, HPInfections
- Clinical Operation & Pharmacovigilance experience in:
Oncology, CNS, Pain, Neurology, Gynecology, Dermatology, Trauma surgery, Orthopedics, Tissue Engineering, Cardiology, Gastrointestinal Diseases, Tropical Medicine, Infectious Diseases, Rheumatology, Urology, Hematology, IBD, Telemedicine.
- Operational experience in RCTs and NIS, as well as PASS.
- Medical Writing experience in IMPDs, CTPs, CSRs, Narratives, DSURs, PSURs, CTDs, RMPs, Pre- & Clinical DP, BP and Clinical Portfolio DP as well as scientificdossiers.
- Practical discovery, scientific experience and a track record in the area of Drug Development, gained in substantial research based in CROs, biopharmaceutical companies.
- Ability to possess soft and managerial skills in order to facilitate project work with colleagues across multiple research sites.
- Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal, intercultural and influence management skills.
- Ability to confidently lead a team, to define problems and seek alternate solutions based on solid scientific judgment, able to balance risk vs. benefit with ease and consistency.
o Additionally have entrepreneurial skills and be comfortable with marketing-oriented, commercial thought.
- Strong intercultural orientation and an interest in a multicultural environment with a proven track of Malaria research (WHO in Africa, Latin-America and Asia) and 2 years of structuring clinical research activities (matching academic and industrial needs)in Saudi Arabia (KSA).
- Strong leadership style and a stable personality, possessing social competence and distinct management abilities.
- Excellent communication skills and the ability to think “out of the box” with the experience in managing multiple tasks.
- Fluency in written and spoken English with some basics in Czech, French, Italian and Arabic.
- Jan. to March 2026 – IP Strategy Bootcamp – successful participation of the course organized at the European Patent Academy at the EPO.
Experience
Professional experience10+ years
Freelancer since2009
Languages
GermanNative speakerEnglishFluentItalianBasic knowledge