Strategic Consulting Life Sciences (Pharma / Biotech)
- Verfügbarkeit einsehen
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- auf Anfrage
- 85560 Ebersberg
- Europa
- de | en
- 08.03.2022
Kurzvorstellung
Qualifikationen
Projekt‐ & Berufserfahrung
3/2017 – offen
Tätigkeitsbeschreibung
Key Responsibilities
* Accountable Business Team Head for most advanced program and key company asset (anti-CD19 mAb; tafasitamab)
* Ensure readiness for EU + US registration and commercialization
* Guide multiple FDA and EMA interactions to define clinical and regulatory strategies as well as CMC requirements (phase III/registration, Breakthrough
Therapy Designation, PRIME designation)
* Drive scalability-model of combining internal and external resources in the environment of a growing organization
* Guide regular review and feedback from international collaborations (industry partners, authorities, institutional and medical-scientific community)
Significant Results
Won exclusive FDA status of "breakthrough therapy" for high-need medicine in oncology. Enables significantly earlier market access and provided competitive edge. Drove change process of implementing company transformation from a development focused organization towards integrating market launch readiness and product commercialization.
Pharmazie
12/2015 – offen
Tätigkeitsbeschreibung
Key responsibilities
* Build and lead a newly created Project Management group within company driving value creation in the proprietary oncology and immunology portfolio
* Establish state-of-the-art Project Management and Lean Governance principles in a fit-for-purpose approach in order to further strengthen the late-stage development position of company.
* Integrate research and development units to optimize value creation along key inflection points during drug development
* Lead assigned company-wide strategy projects and change initiatives
Significant Results
Successfully established a project management department to foster product centricity from a personnel, financial and company oversight perspective.
Pharmaforschung
5/2012 – offen
Tätigkeitsbeschreibung
Key Responsibilities
* Lead international cross-functional teams to ensure speed and excellence of biopharmaceutical drug development in oncological diseases including budget and resource oversight
* Conduct portfolio reviews and gap analyses to prepare portfolio decisions. Integrate science and business perspectives to identify new opportunities and translate strategy ideas into projects
* Steer due diligence reviews for assigned in-licensing projects (drug and/or technology candidates) and participate in commercial negotiations
Lead international cross-functional teams to ensure speed and excellence of biosimilars´ development including budget and resource oversight
* Support the establishment of the biosimilars business as a separate unit
* Ensure the integration of a new class of molecules through deep functional involvement and hands-on creative, out-of-the-box thinking approaches
* Guide multiple FDA and EMA interactions to define clinical and regulatory strategies as well as CMC requirements in unprecedented regulatory pathways (phase 1 PK, phase III, in depth quality/CMC advices)
* Coach and mentor (Junior) Program Leaders
Significant Results
Established a new biopharmaceutical product class in highly competitive and rapidly changing environments. Successfully established a start-up business unit within the larger corporation. Advanced the development and commercialization concept of a new molecule class. Secured market registration readiness of key portfolio compound [Cytelzo ® ] and top 3 position in the EU market.
Pharmaforschung
Ausbildung
München
Weitere Kenntnisse
With >15 years of experience in the successful development, approval and market introduction of biopharmaceutical drugs (focus on oncology and immunology), I have mastered the strategic and operational armamentarium of the following areas:
- P&L responsibility for development portfolios of complex R&D projects.
- International project management: result-oriented management of international, cross-
functional and cross-location projects in the life sciences business.
- Profitability increase: Development and consistent implementation of strict cost management based on clearly defined milestones along the entire pharmaceutical value chain.
- Efficiency improvement: Optimized capacity planning through flexible integration of internal and scalable external resources.
- Change Management: development of organisational structures to focus on products from personnel, budgetary and oversight perspective. Establishment of lean structures, fit-for-purpose governance principles and corporate standards for planning processes, executive reporting and governance.
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Europäische Union
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