Life Sciences Consultant
DR. LANG MANAGEMENT CONSULTING
(Pharma und Medizintechnik, < 10 Mitarbeiter)
Schlagwörter
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.
Projekthistorie
06/2018
-
bis jetzt
Entrepreneurial personality with long-standing leadership experience in international project management and as business unit head. Creates value in competitive and highly regulated environments.
- Lead performant business unit as a direct result of sustainable P&L management.
- Familiar with virtual company settings and start-up environments as well as multinational organizations in pharmaceutical and biotech industries.
- Experienced change leader. Stands for lean structures, fit-for-purpose governance principles and state-of-the-art processes and tools. Creates competitive advantage through efficient cooperation and fast decision making.
- Seasoned expert for complex high-priority projects in oncology and immunology during late-stage drug development and registration.
- Strong negotiator and tactician during numerous interactions with US and EU regulators. Reaches filing readiness.
- Esteemed coach and mentor. Valued and agile sparring partner for peers and C-level executives.
Proven track-record of achievements in late-stage drug development and registration in oncology and immunology.
- Won exclusive FDA status of „breakthrough therapy“ for high-need medicine in oncology. Enables significantly earlier market access and provides competitive edge.
- Established biosimilars as new biopharmaceutical product class in leading pharmaceutical company. Secured market registration readiness of key portfolio compound and top 3 position in the EU market.
- Responsible for Biotech oncology lead asset in pivotal clinical development, during product registration and approval as well as EU market introduction. Secured stand-alone position in the EU market.
- Successfully completed the non-clinical transition of a blockbuster project towards the pivotal clinical development phase. Enabled competitive first-in-class advantage.
- Responsible for the entry of Biotech lead asset into clinical phase I in a virtual company setting. Significant increase of value proposition of a start-up company.
Profound experience in holistic portfolio reviews and assessment of licensing opportunities as well as value generation opportunities along the complete pharmaceutical value chain.external resources. Increases efficient resource utilization.
Mandates organizational readiness in complex scientific and highly competitive environments. Stands for product-centricity from a personnel, financial and company oversight perspective.
Pragmatic and result-driven entrepreneur with the ability to jointly develop the vision of a product and convincingly transport it through simplicity and clarity.
Self-confident leader of negotiations with top executives. Creates commitment and reaches solutions in the best company interest.
03/2017
-
05/2018
VICE PRESIDENT, HEAD OF BUSINESS TEAM
MORPHOSYS AG
(Pharma und Medizintechnik, 250-500 Mitarbeiter)
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.
12/2015
-
02/2017
VICE PRESIDENT, HEAD PROJECT MANAGEMENT
MORPHOSYS AG
(Pharma und Medizintechnik, 250-500 Mitarbeiter)
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.
11/2014
-
11/2015
INTERNATIONAL PROJECT LEADER
BOEHRINGER INGELHEIM GMBH, INGELHEIM
(Pharma und Medizintechnik, >10.000 Mitarbeiter)
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
Significant Results
Established a new biopharmaceutical product class in highly competitive and rapidly changing environments. Secured market registration readiness of key portfolio compound [Cytelzo ® ] and top 3 position in the EU market.
* 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
Significant Results
Established a new biopharmaceutical product class in highly competitive and rapidly changing environments. Secured market registration readiness of key portfolio compound [Cytelzo ® ] and top 3 position in the EU market.
05/2012
-
10/2014
GLOBAL PROGRAM LEADER
BOEHRINGER INGELHEIM PHARMA GMBH & CO.
(Pharma und Medizintechnik, >10.000 Mitarbeiter)
Key Responsibilities
* 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 within the Boehringer Ingelheim corporation
* 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
Successfully established a start-up business unit within the larger corporation. Advanced the development and commercialization concept of a new molecule class.
* 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 within the Boehringer Ingelheim corporation
* 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
Successfully established a start-up business unit within the larger corporation. Advanced the development and commercialization concept of a new molecule class.
Reisebereitschaft
Verfügbar in den Ländern
Deutschland
