DRUG, BIOLOGICS, DRUG/BIOLOGIC-DEVICE, R&D DIRECTOR. Directed/Created strategies, study designs, implementation, reporting, and regulatory submissions for biologics, biologic/device, and medical device projects. Led global cross-sector, cross-functional drug-device combination and drug discovery project teams across J&J companies (Pharma, MD&D, Consumer) and academia. Successful leader in matrix organizations requiring the ability to influence without authority. Goal-oriented leader with proven ability to efficiently deliver creative solutions to complex problems, from discovery to regulatory filing and post-launch support. Key contributor to successful regulatory submissions (INDs, BLA, MAA, 510k). EXPERTISE • Immunology/Inflammation • Drug Discovery • Drug Development • Project Management • Preclinical Development • Biologics • Medical Devices • Drug-Device Combination Products

Highlights:

• New Jersey
• Pennsylvania
• Drug Development
• Project Management
• Medical Devices
• Biologics