Senior Medical Director, Clinical Oncology Development

Menarini Stemline; United States; On-site; USD 285,000 - 395,000; Full time

Benefits offered by this job

Bonus program

Long-term incentive plan (LTI)

401(k) plan with company match

Health insurance

Job summary

Menarini Stemline is seeking a Senior Medical Director, Clinical Development, Solid Tumors to lead global oncology clinical development programs, focused on strategic planning and execution for breast cancer assets. You will shape study designs, safety monitoring, and regulatory submissions with cross-functional teams across regions.

The role emphasizes leadership, scientific rigor, and the ability to drive timelines in a fast-paced environment while coordinating with regulatory agencies and key

Qualifications

• Medical Degree with 7+ years pharma/biotech experience.
• Board certified oncologist and/or oncology training preferred.
• Experience developing clinical strategy for oncology products (Phase I-III) leading to regulatory submission(s).
• Working knowledge of GCP, ICH, FDA, and EMEA regulations.
• Excellent written and verbal communication with all levels.
• Ability to lead cross-functional teams and meet timelines.
• Experience with data analysis, interpretation and clinical publications.
• Ability to manage regulatory interactions and approvals.

Responsibilities

• Represent the clinical science line function on global program teams.
• Lead development of clinical study protocols and related documents.
• Perform medical monitoring and safety data review.
• Take medical responsibility in data analysis and reporting for submissions.
• Contribute to site training, initiation, activation and site engagement.
• Maintain focus on robust study conduct and quality data generation.
• Demonstrate ability to shorten development cycles with innovative clinical strategies.
• Responsible for phase I – III clinical development of products.
• May oversee Medical/Scientific Directors and Clinical Scientists.

Skills

Oncology expertise

Clinical development leadership

Medical monitoring

Regulatory submissions

GCP/ICH knowledge

Communication skills

Education

Medical Degree

Board-certified oncologist

Job description

Menarini Stemline is seeking a Senior Medical Director, Clinical Development, Solid Tumors to lead global oncology clinical development programs, focused on strategic planning and execution for breast cancer assets. You will shape study designs, safety monitoring, and regulatory submissions with cross-functional teams across regions.

The role emphasizes leadership, scientific rigor, and the ability to drive timelines in a fast-paced environment while coordinating with regulatory agencies and key