(Senior) Medical Director, Clinical Development, Solid Tumors

About the role

This role drives the global clinical development strategy in 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 guiding clinical development and regulatory submissions, including responsibility for the design and execution of first-in-human through registration-enabling studies.

Responsibilities

• Represent the clinical science 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, identifying potential signals, responding to site inquiries, and collaborating with CRO medical monitors as needed.
• Take medical responsibility for data analysis and interpretation, ensuring 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 quality data generation.
• Develop unique and innovative clinical strategies to shorten the development cycle amid an evolving regulatory landscape.
• Oversee Phase I–III clinical development of products.
• May oversee the work of Medical and/or Scientific Directors and Clinical Scientists on the same or related programs.
• Act as clinical lead and actively engage with opinion leaders in the disease area(s).

Requirements

• Medical Degree with 5+ years of pharma/biotech experience.
• Board-certified oncologist and/or training in oncology is strongly preferred.
• Experience developing clinical strategy for oncology products (Phase I-III) leading to successful regulatory submission(s) is required.
• Training in Breast Cancer and/or experience developing Breast Cancer compounds within the industry is required.
• Recognized expert in clinical trials with a working understanding of statistical principles, medical monitoring, and demonstrated ability to perform literature research, analyses, and author clinical trial publications.
• 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 functions such as Regulatory, Medical Affairs, Statistics, PK/PD, Commercial, HEOR, or others as required.
• Experience communicating and interacting with investigators, KOLs, regulatory agencies, and advisors.
• Experience with data analysis, interpretation, and clinical relevance.
• Solid knowledge of compliance and global regulatory requirements (ICH) for pharmaceutical development.
• Proven ability to represent the company’s interests effectively in interactions with partners and regulatory agencies.
• Ability to lead a dynamic group in a fast-paced, hands-on environment with scientific rigor and creative solutions.
• Ability to develop and implement strategic growth plans.
• Prior leadership experience preferred.
• Comfortable with ambiguity while being self-motivated and timeline-driven.

Schedule

This is a remote-based role with expectations for business travel and onsite presence approximately 20%. The position is classified as a corporate office role, and New York state income taxes will be withheld for all corporate office employees, regardless of work location.