Senior Medical Director, Late Development, Breast Oncology

Role Summary

This position is for a Senior Medical Director within the atirmociclib program. This individual contributor will be responsible for supporting clinical trial(s) and lead sub teams in clinical development. The successful candidate should ideally have prior experience in clinical trials, supporting development programs, health authority interactions and demonstrated leadership capabilities to ensure that 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 development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team.
• Provide clinical development leadership across several study teams.
• Serve as the Clinical Development Lead on subteams including for Marketing Authorization Applications.
• Collaborate with the Global Development Team to create and refine development strategies.
• Represent the company in external engagements or as committee member in joint collaborations.
• Collaborate with Clinical Scientists to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.
• Maintain a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.

Qualifications

• Medical degree with 5+ years of industry experience
• Clinical oncology experience (typically 4+ years)
• Board certified/eligible in oncology or equivalent preferred
• Breast Oncology experience (2+ years)

Skills

• Clinical development leadership
• Medical monitoring and safety assessment
• Regulatory documentation and interactions with health authorities
• Data interpretation and strategic development planning
• Cross-functional collaboration and external representation

Education

• Medical degree (typical requirement; see Qualifications)

Additional Requirements

• Travel to scientific conferences / meetings several times per year, as needed
• Relocation support available
• Hybrid work location