A seasoned Drug Development Executive with a proven track record in strategic business development and leadership, driving significant growth and innovation in the pharmaceutical and biotech industries.
Expert in managing large, diverse teams and overseeing complex R&D pipelines, with successful regulatory approvals in the US and EU, including innovative approaches in oncology and immunology.
Demonstrated excellence in corporate governance and strategic decision-making as a Board Member, with a focus on risk management and shareholder representation in the pharmaceutical sector.
Led the design and execution of pivotal clinical studies, contributing to the first 2L approval in R/R Diffuse Large B-Cell Lymphoma, showcasing a commitment to advancing global human health.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Doctor of Medicine
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Drug Development, Medical Affairs, Oncology, Immunology, Regulatory Affairs, Leadership, Research and Development, FDA, Pharma, BioTech
Key-Facts
Extract from previous activities
Pharmaceutical Company
Member of the Board of Directors
Corporate Governance
Strategic Decision Making
Representation of Shareholders
Risk Management
Communication
Biotechnology Company
Interim Chief Research and Development Officer
Department size: 350 employees: Boston, USA; Munich, Germany
7 Direct Reports: Drug Development and Medical Affairs (including patient safety, translational medicine, PK/PD), Regulatory Affairs, Clinical Operations, Research, Biostatistics, Business Operations, US R&D
US and EU regulatory approval of a new medication using innovative Real-World data approach leading to first 2L approval in R/R Diffuse Large B-Cell Lymphoma
Oversight of entire Research and Development pipeline
US IPO at Nasdaq
Constellation acquisition
Design/execution of three large pivotal studies in 1L Diffuse Large B-Cell Lymphoma, 1L Myelofibrosis, R/R Follicular Lymphoma
Pharmaceutical Company
Interim Global Head Clinical Development
Department size: 220 employees
9 Direct Reports: 3 Clinical Unit Heads, Heads of Biostatistics and Submission Management, Clinical Operations, Preclinical Development, Drug Supply, Bioanalytics, Clinical Pharmacology, Communications
6 Regulatory filings in US and EU, 2 Regulatory Approvals for Biosimilars in the US and EU
Clinical presenter at Advisory Committee Meeting at FDA
Interim Head of clinical business development strategy team