Executive Medical Director, Clinical Development, Breast Cancer

This is a remote base position classified as a corporate office role. In accordance with the New York state employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of work location.

About the Role

The Executive Medical Director, Clinical Development, Solid Tumors will drive the global clinical development strategy for solid tumors, specifically Stemline’s Breast Cancer product, Elacestrant. You will provide critical input into the strategy, development, management, and implementation of Phase 1-4 clinical studies, including a registration-enabling Phase 3 study, while collaborating closely with Clin Ops colleagues and leading multidisciplinary teams.

Responsibilities

• Represent the clinical line function on global program team(s) and contribute to strategic planning and execution of the clinical development plan for assigned solid tumor assets.
• Lead the development of clinical study protocols, protocol amendments, study guides, protocol training materials, and other clinical study-related documents based on the global development plan.
• Perform medical monitoring, including safety data review, signal detection, and responses to site inquiries, while collaborating with CRO medical monitors as needed.
• Take medical responsibility for data analysis, interpretation, reporting, and communication to ensure consistency and relevance of medical content across Clinical Study Reports, health authority briefing books, and NDA/BLA submission documents.
• Contribute to operational aspects of study conduct and patient enrollment, including site training, initiation, activation, and engagement activities.
• Maintain focus on robust study conduct and high-quality data generation.
• Develop innovative clinical strategies to shorten the development cycle in an evolving regulatory landscape.
• Oversee Phase I–IV clinical development of products, with a primary focus on a pivotal Phase 3 trial.
• May oversee the work of Medical and/or Scientific Directors and Clinical Scientists on related programs.
• Act as clinical lead and engage with key opinion leaders (KOLs) in the disease area(s).
• Represent the company’s interests effectively in interactions with partners and regulatory agencies.

Requirements

• Medical Degree with 12+ years of pharma/biotech experience.
• Board certification in oncology and/or oncology training is strongly preferred.
• Training in Breast Cancer and/or experience developing Breast Cancer compounds in the industry is strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I–IV) leading to successful regulatory submissions is required.
• Recognized expertise in clinical trials, including understanding of statistical principles, medical monitoring, literature research, data analysis, and clinical trial publication authoring.
• Working knowledge of GCP, ICH, FDA, and EMEA regulations.
• Excellent written and verbal communication skills across all levels of the organization.
• Ability to work cross-functionally with oncology development teams (Operations, Regulatory, Medical Affairs, Statistics, PK/PD, Commercial, HEOR, etc.).
• Experience communicating with investigators, KOLs, regulatory agencies, and advisors.
• Proven ability to analyze, interpret, and apply clinical data with scientific rigor.
• Solid knowledge of compliance and global regulatory requirements (ICH) for pharmaceutical development.
• Ability to lead a dynamic team in a fast-paced, hands-on environment.
• Strong scientific standing among peers and a track record of creative problem-solving.
• Comfortable with ambiguity while remaining self-motivated and timeline-driven.

Benefits

• Fidelity 401(k) with company match.
• Anthem Premier PPO and HDHP insurance plans.
• Company-paid Basic Life & AD&D insurance.
• Pre-tax FSA/HSA programs.

Pay

Base Salary Range: $300,000 – $400,000 plus annual bonus and long-term incentives.