Executive Director Solid Tumor Clinical Development

0750 Stemline Therapeutics Inc; New York (NY); On-site; USD 300,000 - 400,000; Full time

Job summary

Menarini Stemline seeks an Executive Director, Clinical Development, Solid Tumors to lead global strategy for solid tumor programs, including the Elacestrant program. You will guide Phase 1-4 development, regulatory submissions, and cross-functional collaboration with Clin Ops and other teams.

The role requires a Medical Degree with 12+ years in pharma/biotech, strong leadership, and a proven track record in regulatory success within oncology.

Qualifications

• Medical degree with 12+ years pharma/biotech experience.
• Oncology expertise or board certification strongly preferred.
• Experience developing oncology clinical strategies (Phase I–IV).
• Knowledge of GCP, ICH, FDA, and EMEA regulations.
• Excellent written and verbal communication across all levels.

Responsibilities

• Represent the clinical line on global program teams and strategic planning.
• Lead development of clinical study protocols and related documents.
• Monitor safety data, respond to site inquiries, and coordinate CRO monitors.
• Interpret data and contribute to regulatory submissions and briefs.
• Drive site training, initiation, activation and ongoing engagement.

Skills

Strategic leadership

Cross-functional collaboration

Strong communication

Regulatory knowledge

Education

Medical Degree

Job description

Menarini Stemline seeks an Executive Director, Clinical Development, Solid Tumors to lead global strategy for solid tumor programs, including the Elacestrant program. You will guide Phase 1-4 development, regulatory submissions, and cross-functional collaboration with Clin Ops and other teams.

The role requires a Medical Degree with 12+ years in pharma/biotech, strong leadership, and a proven track record in regulatory success within oncology.