Medical Director, Clinical Science - Solid Tumor

Role Summary

Medical Director, Clinical Science, Solid Tumor — leads global clinical development strategy for solid tumor programs, coordinating multi-regional teams to create and execute a comprehensive development plan that supports regulatory approvals across US, EU, and Japan. Applies clinical and scientific judgment to development decisions and interfaces with senior leadership to set strategic direction.

Responsibilities

• Lead Global (US/EU/Japan) Development Team and represent Clinical Science on the Global Development Team to ensure alignment with the global strategy.
• Establish and drive Development Team strategy and deliverables, producing the Development Strategy, Clinical Development Plan, and Clinical Protocols; assess scope, complexity, and budget; maintain a state-of-the-art plan with contingency strategies.
• Make high-impact global decisions by monitoring data from ongoing studies, assessing medical implications, and recommending changes to development plans or study designs; understand implications for timelines and labeling.
• Drive synopses, protocols, and study execution; provide guidance to other clinical scientists; present study conclusions to management and integrate results into overall compound strategy.
• Interpret data with medical significance for patients and determine how results impact overall program strategy.
• Oversee medical monitoring activities, assess protocol conduct and subject safety, coordinate with Pharmacovigilance, and ensure scientific integrity of studies.
• Direct interactions with regulatory authorities and key opinion leaders; establish strategy for compounds and oversee documentation and communications supporting regulatory positions.
• Identify and evaluate business development opportunities; conduct due diligence and develop clinical development plans for alliances or in-licensing; interface with partners to achieve strategic goals.
• Lead and mentor clinical science staff; recruit, manage, and develop teams; conduct performance reviews and development planning.

Education

• MD, MD/PhD, or internationally recognized equivalent, plus 5 years of clinical research experience in pharmaceutical industry, CRO, or academia.

Skills

• Excellent communication and influencing skills; able to engage executives and external partners; proactive problem-solving.
• Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities.

Qualifications

• Education/Experience as above.
• Training and experience in Hematology/Oncology and/or Medical Oncology, especially solid tumors, preferred.
• Experience in immune-based therapies and/or antibody-drug conjugates, preferred.
• Late-phase clinical development and NDA/MAA/Submissions experience, preferred.
• Proven leadership of clinical development teams across multiple regions.

Additional Requirements

• Travel: ability to travel to meetings or client sites, including overnight trips; some international travel may be required; approximately 15–25% travel.