Executive Medical Director, Clinical Development, Breast Cancer

Executive Director, Clinical Development, Solid Tumors — reports to Vice President, Clinical Development, Solid Tumors. Permanent position. Note: This role is classified as a corporate office position; per New York state employer convenience rules, Stemline will withhold New York state income taxes for all corporate office employees regardless of work location.

Overview

The Executive Medical Director, Clinical Development, Solid Tumors will be responsible for driving the global clinical development strategy in solid tumors, specifically Stemline’s Breast Cancer product, Elacestrant. The incumbent will provide critical input into the strategy, development, management, and implementation of Phase 1–4 clinical studies including a registration-enabling Phase 3 study, working closely with Clinical Operations colleagues and leading multi-disciplinary teams charged with guiding clinical development and subsequent regulatory submissions.

Responsibilities

• Represent the clinical line function on global program team(s) and contribute to strategic planning and execution of clinical development plan for the assigned assets being developed in solid tumors.
• 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 (safety data review and identify potential signals), responses to site inquiries, and work with CRO medical monitors when appropriate.
• Take medical responsibility in data analysis and interpretation, reporting and communication to ensure consistency and relevance of medical content and scientific messages across Clinical Study Reports, health authority briefing books, and NDA/BLA submission documents.
• Contribute to operational aspects of study conduct and patient enrolment efforts including participation in site training, initiation and activation and subsequent site engagement activities.
• Maintain focus on robust study conduct and quality data generation.
• Demonstrate the ability to develop unique and innovative clinical strategies to significantly shorten the development cycle in the face of an evolving regulatory landscape.
• Responsible for Phase I–IV clinical development of products; primary focus includes a pivotal Phase 3 trial.
• May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs.

Qualifications

• Medical Degree with 12+ years pharma/biotech experience.
• Board certified oncologist and/or training in oncology strongly preferred.
• Training in Breast Cancer and/or experience developing Breast Cancer compounds in the industry strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I–IV) leading to successful regulatory submission(s) required.
• Recognized expert in clinical trials: understanding of statistical principles, medical monitoring; demonstrated ability to perform literature research, analyses, and author clinical trial publications.
• Working knowledge of GCP, ICH, FDA, and EMA regulations.
• Excellent and effective written and verbal communication skills with all levels of the organization.
• Ability to work cross-functionally, partnering with oncology development functions such as Operations, Regulatory, Medical Affairs, Statistics, PK/PD and others such as commercial and/or HEOR or other functions as required.
• Experience communicating and interacting with investigators, KOLs, regulatory agencies, and advisors.
• Experience working with the principles and techniques of data analysis, interpretation, and clinical relevance.
• Solid knowledge of compliance and global regulatory requirements (ICH) for development of pharmaceutical candidates/products (required).
• Proven ability to represent the Company’s interest effectively in interactions with partners and regulatory agencies.
• Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s).
• Ability to lead a dynamic group in a fast-paced and hands-on environment.
• Excellent scientific standing among peers and the ability to address issues with scientific rigor and creative solutions.
• Ability to develop and implement strategic growth plans.
• Prior leadership experience preferred.
• Comfortable with ambiguity yet self-motivated and timeline driven.

Pay

Base Salary Range: $300,000 – $400,000.

Benefits

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

About Menarini Group

Founded in 1886 in Naples as Farmacia Internazionale, Menarini moved to Florence in 1915 where the Group’s headquarters remain. With nearly 135 years of history, Menarini is a leading international biopharmaceutical company present in 70 countries, products sold in 140 locations, and approximately 18,000 employees. The Group operates 18 manufacturing sites across six continents, including a biotech plant for monoclonal antibodies. Menarini’s oncology commitment includes a pipeline of five investigational compounds for haematological and solid tumours, strengthened by the 2020 acquisition of Stemline Therapeutics (adding commercial and clinical-stage assets such as Tagraxofusp for BPDCN, and Elacestrant — an oral SERD approved by FDA in January 2023 and EMA in September 2023 for hormone receptor-positive advanced breast cancer). Menarini also holds exclusive rights to commercialize Selinexor (a first-in-class oral SINE compound) in Europe, Latin America, and other regions. Through affiliate Menarini Silicon Biosystems, the company pioneers liquid biopsy diagnostics including the FDA-cleared CELLSEARCH CTC test and the CELLSEARCH CMMC enumeration LDT for multiple myeloma. Menarini’s vision integrates innovative therapeutics with advanced liquid biopsy-based diagnostics for faster, more effective, and precise patient management.