Global Development Lead, Late-Stage Oncology Clinical Development

ROLE SUMMARY

The Global Development Lead will be responsible for defining and executing on the development strategy of two assets at different development stages. Reporting to the Vice President, GYN/GI/Melanoma Therapeutic Area Head, the successful candidate should have demonstrated proficiency in leading and/or supporting development programs, cross-functional collaboration, and represent program(s) externally.

ROLE RESPONSIBILITIES

• Lead product specific Global Development Teams
• Serve 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 TIVDAK in cervical cancer and another new molecular entity entering late-stage clinical development.
• Endorse clinical decisions in advance of GPT, senior management reviews or governance bodies
• Provide oversight and management responsibilities of medical director(s)
• Accountable for the clinical development strategy, trial design, execution, and delivery of trial results
• Accountable for integrating regulatory, statistical and other internal and external stakeholder input into study designs
• Serve 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
• Accountable with clinical pharmacology for defining and identifying optimal dose and schedule selection
• Accountable with regulatory for health authority interactions
• May participate in evaluating business development opportunities

BASIC QUALIFICATIONS

• Medical degree or an advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience
• 5+ years of experience leading diverse teams
• Prior management responsibilities of medical directors or clinical scientists

PREFERRED QUALIFICATIONS

• Board certified/eligible in oncology or equivalent
• Experience across multiple phases of clinical development and across drug classes in oncology
• Experience in leading NDA, BLA or MAA