16.05.2025 aktualisiert
60 % teilweise verfügbar
Strategic Consulting Life Sciences
Ebersberg, Deutschland
Deutschland
Dr. rer.nat.Skills
Benefit from my profound leadership experience and successful P&L management of development portfolios in medium-sized companies as well as corporate environments in the life sciences industry.
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:
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.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2018
Sprachen
DeutschMutterspracheEnglischverhandlungssicher
Projekthistorie
Entrepreneurial personality with long-standing leadership experience in international project management and as business unit head. Creates value in competitive and highly regulated environments.
Dr Lang Consulting GmbH brings 20 years of experience in pharmaceutical R&D, the successful development, manufacture and registration of biopharmaceutical drugs (focus on oncology and immunology).
Managing Director Dr. Markus A. Lang has profound leadership experience and successful P&L management of development portfolios in medium-sized companies as well as corporate environments in the biotech & pharma industry.
He made key contributions to successful development of several marketed drugs [Monjuvi®, Cyltezo®, Removab®, Pradaxa®]
Supports his clients also with profound experience in holistic portfolio reviews and assessment of licensing opportunities.
Dr. Markus A. Lang mandates organizational readiness in complex scientific and highly competitive environments and stands for product-centricity from personnel, financial and company oversight perspective.
As Biotech Entrepreneur Dr Markus A. Lang supports companies in the areas of
Dr Lang Consulting GmbH brings 20 years of experience in pharmaceutical R&D, the successful development, manufacture and registration of biopharmaceutical drugs (focus on oncology and immunology).
Managing Director Dr. Markus A. Lang has profound leadership experience and successful P&L management of development portfolios in medium-sized companies as well as corporate environments in the biotech & pharma industry.
He made key contributions to successful development of several marketed drugs [Monjuvi®, Cyltezo®, Removab®, Pradaxa®]
Supports his clients also with profound experience in holistic portfolio reviews and assessment of licensing opportunities.
Dr. Markus A. Lang mandates organizational readiness in complex scientific and highly competitive environments and stands for product-centricity from personnel, financial and company oversight perspective.
As Biotech Entrepreneur Dr Markus A. Lang supports companies in the areas of
- Venture Development
- C-Level Biotech Management. Organizational development
- Preparation & execution of fundraising campaigns
- Development and execution of drug development strategies
- Lifecycle Focus: Late Discovery through (early) Preclinical to Phase I IND Readiness and/or phase II PoCC
- Therapeutic entities: Biologics, ADCs and other moieties in primarily oncological and immunological disorders
Key Responsibilities
* Accountable Business Team Head for MorphoSys´ 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.
* Accountable Business Team Head for MorphoSys´ 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.
Key responsibilities
* Build and lead a newly created Project Management group within MorphoSys 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 MorphoSys
* 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.
* Build and lead a newly created Project Management group within MorphoSys 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 MorphoSys
* 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.