Experience

Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Sr. Director, Global Development/Medical Affairs Technology Solutions

  • Dec 2022 - Present

  Tarrytown, New York, United States

• Dir, Global Clinical Operations / Global Development Solutions

  • Jul 2019 - Present

  Tarrytown, NY



CMS Global Group

• President

  • Apr 2005 - Jun 2019

  NY, NJ, CA Key Contributions: Hands-on approach with clients to provide innovative solutions and tactical execution for product development, commercialization, and digital healthcare. Expertise in medical sciences, technology, and business disciplines. Responsibilities included account management, business development, building cross-functional teams, and hands-on project work. Clients included Ipsen, BMS, Roche, Pfizer, CROs, and Aaron Bernstein Consulting. Sample engagements (and… Show more Key Contributions: Hands-on approach with clients to provide innovative solutions and tactical execution for product development, commercialization, and digital healthcare. Expertise in medical sciences, technology, and business disciplines. Responsibilities included account management, business development, building cross-functional teams, and hands-on project work. Clients included Ipsen, BMS, Roche, Pfizer, CROs, and Aaron Bernstein Consulting. Sample engagements (and responsibilities) included: Business Development and Alliance Management for digital healthcare products (Strategy and PM) Global Alliance Director for a digital medicine product (Alliance Director) Regulatory: IND/NDAs, CSRs, Safety updates, Protocols, IBs, and Regulatory Briefing Documents (SME consultant, and editor) Medical Affairs Operations: IIR, Publications, Medical Information, Review Committees. (Strategy, BA, PM, Change Management) EFPIA-PhRMA Commitments for Responsible Clinical Trial Data Sharing (Strategy and Execution) Product End of Lifecycle (LOE) playbook for Medical functions (Analysist, Content Development, and Training) Show less



Otsuka

• Global Director, Alliance Management & Business Development

  • Oct 2015 - Sep 2016

  Princeton, NJ Key Contributions: Alliance Director for development and commercialization of the first Digital Medicine product (for schizophrenia & major depressive disorder) Proactively managed the alliance across diverse cultures to achieve cross-functional alignment. Negotiated internal consensus, mitigated risk, and managed the program governance to achieve complex goals in a dynamic environment. Improvements were implemented in the alliance strategy, governance, and management.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Global Medical Business Technology

  • Apr 2001 - Apr 2005

  New York, NY Developed and managed technology for Medical Affairs and Clinical Development. Responsibilities included program and vendor management, business analysis, project management, and change management. Programs included e-Clinical Trial applications, patient registries, management/tracking tools for alliance based research programs (Research Grants, Investigator-Initiated Research, Patient Registries), and Review Committees (Marketing, Legal, Regulatory, Medical).

• Project Scientist, Anti-Infective Portfolio

  • Nov 1989 - Apr 2001

  New York Key Contributions: • Anti-Infective Disease Management Team: Designed and managed medical/scientific research programs to establish a new quinolone antibiotic as the preferred therapy in 14 indications. Programs included Phase III/IV clinical trials and academia/industry alliances for surveillance and monitoring of resistance. Chaired Publications Sub-Committee. As Medical Science Liaison, developed innovative collaborations with clinical investigators, KOLs, Key Societies, and patient… Show more Key Contributions: • Anti-Infective Disease Management Team: Designed and managed medical/scientific research programs to establish a new quinolone antibiotic as the preferred therapy in 14 indications. Programs included Phase III/IV clinical trials and academia/industry alliances for surveillance and monitoring of resistance. Chaired Publications Sub-Committee. As Medical Science Liaison, developed innovative collaborations with clinical investigators, KOLs, Key Societies, and patient advocacy organizations. • New Product Development Team: Project Scientist and Alliance Manager Alliance Manager for co-development (Pfizer + XOMA) of an anti-endotoxin MAb (E5) for gram-negative sepsis. Designed and managed two pivotal Phase III clinical programs, Outcomes Research (OR), and an emergency use program.



American Foundation for Aids Research (AmFar)

• Medical/Scientific Editor

  • Jun 1998 - Jun 1999

  Greater New York City Area Medical/Scientific Editor for two quarterly journals: AIDS/HIV Experimental Treatment Directory, and AIDS Medicines in Development.