(Senior) Medical Director, Clinical Development, Solid Tumors

About the Role

This remote-based position drives the global clinical development strategy for solid tumors, providing critical input into the development, management, and implementation of Phase 1-4 clinical studies. The Medical Director will lead multi-disciplinary teams in guiding clinical development and regulatory submissions, including the design and execution of first-in-human through registration-enabling studies.

Responsibilities

• Represent the clinical science function on global program teams, contributing to strategic planning and execution of the clinical development plan for assigned solid tumor assets.
• Lead the development of clinical study protocols, amendments, study guides, training materials, and other clinical study-related documents aligned with the global development plan.
• Perform medical monitoring, including safety data review, signal identification, and responses to site inquiries, collaborating with CRO medical monitors as needed.
• Take medical responsibility for data analysis, interpretation, and reporting 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.
• Develop innovative clinical strategies to shorten the development cycle in an evolving regulatory landscape.
• Oversee Phase I–III clinical development of products and may manage Medical/Scientific Directors and Clinical Scientists on related programs.
• Engage with investigators, key opinion leaders (KOLs), regulatory agencies, and advisors to represent the company’s interests effectively.
• Lead a dynamic team in a fast-paced environment, ensuring robust study conduct and high-quality data generation.

Requirements

• Medical Degree with 5+ years of pharma/biotech experience.
• Board certification in oncology and/or oncology training is strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I–III) leading to successful regulatory submissions.
• Training in Breast Cancer and/or experience developing Breast Cancer compounds within the industry is required.
• Expertise in clinical trials, including statistical principles, medical monitoring, literature research, and clinical trial publication authoring.
• Working knowledge of GCP, ICH, FDA, and EMEA regulations.
• Solid understanding of compliance and global regulatory requirements for pharmaceutical development.
• Proven ability to interact effectively with partners, regulatory agencies, and opinion leaders.

Skills

• Excellent written and verbal communication skills across all organizational levels.
• Ability to work cross-functionally with Regulatory, Medical Affairs, Statistics, PK/PD, Commercial, HEOR, and other teams.
• Strong leadership in a fast-paced, hands-on environment with a focus on scientific rigor and creative problem-solving.
• Comfort with ambiguity while maintaining self-motivation and timeline-driven execution.
• Experience in data analysis, interpretation, and clinical relevance.

Schedule

This is a remote-based role with approximately 20% business travel and onsite presence expected.

Pay

Base salary range of $280,000–$350,000, plus annual bonus and long-term incentives.

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.

About the Company

The Menarini Group is an established Italian pharmaceutical company with a 139-year history, operating globally across 70 countries and selling products in over 140 locations. With approximately 18,000 employees and 18 manufacturing sites, Menarini is a major producer of therapeutics and diagnostics, with a strong focus on oncology.

Menarini Stemline, acquired in 2020, drives the company’s U.S. oncology expansion, specializing in innovative therapeutics and advanced diagnostics for hematological and solid tumors, particularly in women’s health, including breast and gynecologic cancers. Key assets include Tagraxofusp, Selinexor, and Elacestrant, alongside a robust pipeline of novel compounds. The company also invests in liquid biopsy diagnostics through Menarini Silicon Biosystems, offering FDA-cleared solutions like the CELLSEARCH® Circulating Tumor Cell Test.