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
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