Ray Valencia
Senior Director Global Clinical Development Oncology @BioNTech SE
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WORK HISTORY
Senior Director Global Clinical Development Oncology @BioNTech SE
Berlin, DE
Global Senior Director Clinical Development, leading clinical teams with members from several functions, such as preclinical and clinical scientists, clinical operations, etc. in a matrix setting. • Responsible for creating translational & clinical development strategies, to advance several mRNA-based therapies and ADCs into the clinic• Medical monitoring oversight, benefit-risk assessment, analysis and interpretation of safety, efficacy, pharmacodynamics and pharmacokinetic study data• Close interaction with Key Opinion Leaders, investigators and relevant competent Authorities in the U.S, Asia and Europe
EDUCATION
Marburg University
Medicine
Freie Universität Berlin
Medicine
ABOUT RAY VALENCIA
Executive SummarySenior healthcare and life sciences leader with a distinctive hybrid profile spanning clinical practice as a board-certified Radiologist, global clinical leadership in Oncology Drug Development and Translational Medicine, with a deep expertise in Early Clinical Development. My career is defined by a consistent focus on accelerating drug development through implementation of efficient clinical and translational trial strategies, integrating innovative biomarker, imaging, and digital (AI) solutions. Key Achievements and Responsibilities- Designed and implemented early adaptive clinical and translational strategies integrating biomarkers, imaging, and clinical endpoints for 9 oncology assets, including small molecules, Radiopharmaceuticals, mRNA-based therapies & antibody–drug conjugates (ADCs) at Bayer and BioNTech, leading them from preclinical into First-in-Human studies through Proof-of-Concept / Go–No-Go decisions- Advanced 6 radiopharmaceutical imaging assets from preclinical into First-in-Human studies and through Proof- of-Concept / Go–No-Go decisions at Bayer (track record of respective publications)- Contributed to the Phase 2/3, CDx and Real-World-Data strategy for Tafasitamab, supporting successful BLA FDA approval at MorphoSys- Led global cross-functional teams (8–10 members) across Clinical Development and in complex matrix environments, implementing Global Regulatory Interactions, Approval Pathways as well as Cross-functional Leadership and Stakeholder Management- Drove oncology-focused CRO consulting and bid strategy at PRA Health Sciences, optimizing development pathways for biotech and pharma clients- Built expertise in AI-enabled data integration, Real World Data, and clinical development of Software as a Medical Device in oncology and radiology- Recognized for a collaborative, results-oriented leadership style, strong executive communication skills, and the ability to connect healthcare providers, life sciences companies, and clinical stakeholders Well positioned to build, scale, and globally execute translational and clinical development strategies that leverage the company’s industry footprint and portfolio, to deliver improved clinical development success rates and business impact.
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