Clinical Development Executive Medical Director, GI Oncology

Responsibilities

• May lead product specific Global Development Team
• Serves as the subject matter expert on clinical issues
• Work across the organization and on the cross-functional Global Development Team to lead, develop and execute the clinical development plan of one or more indications in alignment with the Lifecycle Management Plan and Integrated Product Plan
• Endorses clinical decisions in advance of GPT, senior management reviews or governance bodies with the GDPL
• Provides oversight and management responsibilities of medical director(s)
• Accountable for the clinical development strategy, trial design, execution, and delivery of trial results with the GDPL
• Accountable for integrating regulatory, statistical and other internal and external stakeholder input into study designs
• Serves as primary interface with Development Review Committee
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
• Oversee the evaluation, interpretation, reporting and presentation of study data
• Accountable with safety for clinical evaluations and safety decisions, escalating to GDPL as necessary
• Accountable with clinical pharmacology for defining and identifying optimal dose and schedule selection
• Accountable with regulatory for health authority interactions, escalating to GDPL as necessary
• May participate in evaluating business development opportunities
• Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring
• Lead peer-to-peer interactions with investigator
• Oversee and provide clinical development leadership across several study teams
• Serves as the Clinical Development Lead on working groups and subteams including for Marketing Authorization Applications and in business development opportunities

Qualifications

• Medical degree or advanced degree with relevant clinical/industry experience (typically 5+ years)
• 7+ years industry experience
• 5+ years of experience leading diverse teams
• Prior management responsibilities of medical directors or clinical scientists
• Late phase drug development experience