Interim Global Clinical Program Director

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

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

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

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