Senior Medical Director, Late Development, Breast Oncology

Role Summary

Senior Medical Director within the atirmociclib program. Responsible for supporting clinical trial(s) and leading sub teams in clinical development. Requires experience in clinical trials, development programs, health authority interactions, and demonstrated leadership to ensure scientific, ethical, and regulatory standards are met.

Responsibilities

• Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring.
• Lead peer-to-peer interactions with investigators.
• Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.
• Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and cross-functional team.
• Provide clinical development leadership across several study teams.
• Serve as the Clinical Development Lead on subteams including for Marketing Authorization Applications.

Qualifications

• Medical degree with 5+ years of industry experience
• Clinical oncology experience (typically 4+ years)

Preferred Qualifications

• Board certified/eligible in oncology or equivalent
• Breast Oncology experience (2+ years)

Skills

• Strategic development planning
• Clinical data interpretation and communication
• Leadership and cross-functional collaboration
• Regulatory documentation and interactions

Education

• Medical degree (MD, DO, or equivalent)

Additional Requirements

• Travel to scientific conferences/meetings several times per year, as needed
• Hybrid work arrangement; relocation support available