Global Development Lead, Late Stage
hace 1 mes
Role Summary
The Senior Clinical Development Lead will be responsible for defining and executing the development strategy of two assets at different 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 representing programs externally.
Key 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 the primary interface with the 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 for safety and clinical pharmacology for defining and identifying optimal dose and schedule selection
- Accountable for 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
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
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