Successfully completed various clinical development projects
Global Clinical Program Director with more than 30 years of experience
Design, implementation, and successful execution of Clinical Development Plans; Phase I-IV
Deep knowledge of all aspects in conducting clinical trials
Excellent communication skills with extensive experience in data presentation, medical leader in interaction with internal and external stakeholders, strong problem-solving skills, self-motivated and pro-active
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Study of Human Medicine, Medical license
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Global Clinical Program Manager, Phase I-IV, Early Development, Development Plans, Patient Safety, Program Management, Oncology, Immunology, Pharma & B
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany
Interim Global Clinical Program Director
Responsible & accountable for global clinical studies as part of a therapeutic program, inclusive strategy
Created clinical development plans and regulatory documents (briefing books, IND) for new indications leading to open INDs
Global lead for the clinical development of a monoclonal antibody in dermatological and rheumatological indications
Reviewed and approved marketing materials
Developed, set up and conducted of non-interventional studies
Managed and oversaw data review, participates in safety review
Responsible for overseeing Project timelines for each project
Biotechnological Company, Germany
Senior Clinical Program Director TA Oncology
Established early clinical development plans
Accountable for the strategic planning, oversight and execution of the program, including the continuous monitoring of the risk-benefit ratio of the clinical development project
Global lead for the early clinical development of a compound in oncology (solid tumors)
Medical monitoring
Oversaw medical project budgets for the respective project(s)
Acted as the key medical point of contact for internal and external stakeholders including providing medical leadership to the cross-functional teams
Pharmaceutical Company, Switzerland
Principal Medical Expert
Principal clinical lead for new drugs and responsible for the respective clinical development plans (Phase IIV)
Designed, executed, monitored and reported the clinical development program incl. life cycle management plan (Phase IIIb/IV trials) for a biological product
Evaluated new indications, development and presentation of respective development scenarios
Clinical lead for the FDA approval of a biological product for four indications
Contributed to the publications related to clinical data and presentation of results at internal and external meeting
Contributed to the medical monitoring activities of ongoing studies