Responsibilities:
- Serve as Clinical Development Lead on subteams, including for Marketing Authorization Applications.
- Conduct medical monitoring activities including eligibility assessment, data review, and safety monitoring.
- Lead peer-to-peer interactions with investigators.
- Act as the point of contact for clinical issues between study teams and investigators.
- Lead and contribute to development and maintenance of clinical trial and regulatory documents with Clinical Scientist and cross-functional teams.
- Collaborate with the Global Development Team to create and refine development strategies.
- Represent the company in external engagements and committee/joint collaboration settings.
- Support regulatory interactions.
- Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings/implications, and communicate to internal and external stakeholders.
- Stay current with latest developments, literature, and guidelines to advise on and drive current/future clinical development plans.
Qualifications (Basic):
- Medical degree with 5+ years clinical/industry experience.
- Hematology/Oncology clinical experience in academia/industry.
- Late-stage clinical development experience.
- Experience overseeing and providing clinical development leadership across several study teams.
- Excellent communication skills to present complex technical concepts across disciplines and levels.
- Strong strategic and analytical skills.
Preferred:
- Leadership/management experience.
- Board certified/eligible in hematology/oncology (preferred).
- Experience across multiple phases of clinical development and across oncology drug classes.
- Late clinical development experience in hematology (highly preferred).