Executive Director, Oncology Clinical Development – Breast Cancer

Menarini Biotech S.r.l.; New York (NY); On-site; USD 300,000 - 400,000; Full time

Benefits offered by this job

401(k) matching

Healthcare insurance

Life & AD&D insurance

FSA/HSA

Job summary

Stemline Therapeutics Inc, a Menarini company, is seeking an Executive Medical Director, Clinical Development (Solid Tumors) to lead global clinical development programs for breast cancer assets, including a pivotal Phase 3. The role requires medical leadership, oncology expertise, and extensive regulatory experience.

Based in New York, NY, with strong cross-functional collaboration across Operations, Regulatory, Medical Affairs, and Statistics.

Qualifications

• Medical Degree with 12+ years pharma/biotech experience
• Board certified oncologist and/or training in oncology preferred
• Breast Cancer experience and compounds development preferred
• Experience crafting oncology clinical strategy across Phases I–IV
• Solid knowledge of GCP, ICH, FDA/EMEA regulations
• Strong written and verbal communication across all levels of the organization
• Ability to lead cross-functional teams and interact with regulators and investigators

Responsibilities

• Represent clinical line function on global program teams and contribute to strategic planning
• Lead development of study protocols and related documents per global plan
• Perform medical monitoring and safety data review, liaising with CRO monitors
• Provide medical input for data analysis, interpretation and regulatory submissions
• Drive site training, initiation, activation and site engagement activities
• Ensure robust study conduct and high-quality data generation
• Lead strategic clinical development initiatives with a focus on accelerating timelines

Skills

Medical leadership

Oncology expertise

Breast cancer

Clinical strategy

GCP/ICH knowledge

Regulatory submissions

Cross-functional leadership

Education

Medical Degree

Job description

Stemline Therapeutics Inc, a Menarini company, is seeking an Executive Medical Director, Clinical Development (Solid Tumors) to lead global clinical development programs for breast cancer assets, including a pivotal Phase 3. The role requires medical leadership, oncology expertise, and extensive regulatory experience.

Based in New York, NY, with strong cross-functional collaboration across Operations, Regulatory, Medical Affairs, and Statistics.