Executive Medical Director, Solid Tumor Clinical Development

Menarini Stemline; United States; On-site; USD 300,000 - 400,000; Full time

Benefits offered by this job

401(k) match

Health insurance

Life insurance

FSAs/HSA

Job summary

Menarini Stemline seeks an Executive Medical Director, Clinical Development, Solid Tumors to drive global clinical development strategy for solid tumor programs, notably Elacestrant. You will lead cross-functional teams, shape Phase 1–4 studies and guide regulatory submissions across major markets.

Responsibilities include protocol development, medical monitoring, data interpretation, and strategic planning with Clin Ops and other functions.

Qualifications

• Medical Degree required with 12+ years pharma/biotech experience.
• Board-certified oncologist strongly preferred.
• Training in Breast Cancer or experience developing Breast Cancer compounds preferred.
• Experience developing oncology clinical strategy (Phase I–IV) leading to regulatory submissions.
• Expertise in clinical trials, literature review, analyses and publications.
• Solid knowledge of GCP, ICH, FDA and EMEA regulations.

Responsibilities

• Represent the clinical line function on global program teams and contribute to strategic planning and execution of the clinical development plan for solid tumor assets.
• Lead development of clinical study protocols and related documents.
• Perform medical monitoring and safety data review; collaborate with CRO medical monitors as needed.
• Provide medical input for data analysis, interpretation and communications for CSRs, briefing books and NDA/BLA submissions.
• Contribute to study conduct and patient enrollment activities including site training and activation.
• Maintain focus on robust study conduct and high-quality data generation.
• Develop innovative clinical strategies to shorten development timelines amid regulatory changes.
• Oversee phase I–IV clinical development with primary focus on pivotal Phase 3 trials.
• May supervise Medical/Scientific Directors and Clinical Scientists.

Skills

Leadership experience

Cross-functional collaboration

Communication skills

Regulatory understanding

Clinical data analysis

oncology product knowledge

Strategic thinking

Project management

Education

Medical Degree

Board-certified oncologist

Breast Cancer training/experience

Tools

GxP knowledge

Job description

Menarini Stemline seeks an Executive Medical Director, Clinical Development, Solid Tumors to drive global clinical development strategy for solid tumor programs, notably Elacestrant. You will lead cross-functional teams, shape Phase 1–4 studies and guide regulatory submissions across major markets.

Responsibilities include protocol development, medical monitoring, data interpretation, and strategic planning with Clin Ops and other functions.