Role Summary
Senior Medical Director within the atirmociclib program. This individual contributor will support clinical trials and lead sub teams in clinical development. The candidate should have experience in clinical trials, supporting development programs, health authority interactions, and demonstrated leadership to ensure the clinical development program meets scientific, ethical, and regulatory standards.
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 the 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
- Required: Medical degree with 5+ years of industry experience
- Required: Clinical oncology experience (typically 4+ years)
- Preferred: Board certified/eligible in oncology or equivalent
- Preferred: Breast Oncology experience (2+ years)
Additional Requirements
- Travel to scientific conferences / meetings several times per year, as needed
- Work location: Hybrid role requiring residence within commuting distance and on-site work an average of 2.5 days per week