Director

• Contribute to and devise clinical pharmacology strategy supporting Organon development assets
• Design, provide rationale for, and oversee phase 1 to 2a study protocols in collaboration with internal and external colleagues
• Serve as medical monitor and/or study director responsible for execution and reporting of TMED studies
• Develop strategic early development plans (EDP) integrating PK/PD modeling, exposure-response relationships, and biomarker strategy to optimize dose selection
• Provide vendor selection input and vendor oversight (CROs, bioanalytical, modeling vendors)
• Author translational medicine and clinical pharmacology components of protocols, clinical study reports, Investigator Brochures, IND subsections, submission modules, briefing books, and regulatory responses
• Participate in health authority meetings and prepare TMED presentations for governance
• Collaborate across preclinical science, data science, clinical operations, regulatory affairs, CMC, project management and other partner groups
• Attend and actively participate in asset development and sub-team meetings, clinical study teams, modeling and vendor meetings
• Contribute to scientific communication and events and engage with regulators, scientific leaders, and physicians as needed

Director, Clinical Pharmacology

Associate Director, Outcomes Research

Associate Director, Outcomes Research

Associate Director, Non-Clinical Safety Assessment

Associate Director, Biopharmaceutics