Strategic Consulting Life Sciences (Pharma / Biotech)

2/2022 – 7/2023

Program lead responsible for time, cost and quality in pre-development and life-cycle projects

F&E Management, Management (allg.), Projektmanagement

12/2021 – 3/2022

TCO model with team developed and approved by local steering committee for further refinement and implementation. Outlook for integration into an overall design-2-service strategy completed

F&E Management, Management (allg.), Projektmanagement

7/2021 – 12/2021

Systematic work-up of existing R&D data to provide solid basis from data and finance perspective for upcoming investor due diligence

F&E Management, Management (allg.), Projektmanagement

3/2017 – 5/2018

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 – 2/2017

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.

Drug Discovery

5/2012 – 11/2015

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.

Drug Discovery