Medical Director, Liver Disease Clinical Development

Jobtailor; Massachusetts; On-site; USD 260,000 - 380,000; Full time

Job description

• Provide clinical and scientific insights to potential new, established, and emerging assets in clinical development, focusing on liver diseases
• Work within project teams to plan, execute, and deliver clinical development activities through registrational studies
• Contribute to indication planning and cross-functional project team discussions
• Support deliverables including the Target Product Profile, clinical development plan, study protocols, and integrated evidence strategy
• Support development and execution of the integrated evidence strategy and oversee R&D evidence generation activities
• Design and execute clinical development plans across advanced development stages
• Oversee clinical study protocols, amendments, investigator brochures, and clinical study reports
• Input to or lead regulatory interactions and documents, including briefing documents, presentations, and responses
• Provide medical monitoring and oversight of participant safety with the Pharmacovigilance Physician
• Lead Medical Governance across projects when acting as physician
• Act as clinical lead for a clinical study and participate in the Study Leadership Team
• Serve as clinical point of contact on the Clinical Matrix Team and across internal and external stakeholders
• Contribute to global regulatory submissions including IND, NDA, BLA, and MAA
• Evaluate business development activities including due diligence
• Contribute to strategic and organizational initiatives in Clinical Development
• Adopt innovative methodologies, digital tools, and technology
• Monitor advances in therapeutic research, clinical trial methodologies, competition, and regulatory developments

Requirements

• Medical degree
• Clinical medical specialty training with board qualification/registration in Internal Medicine or Primary Care / Family Medicine
• Completion of a full clinical residency program leading to board qualification or certification
• Experience working in the pharmaceutical industry in clinical drug development
• Understanding of clinical trial execution from concept to publication
• Direct experience with in-stream medical oversight activities during trial conduct
• Knowledge of ICH guidelines, FDA requirements, and global regulatory expectations
• Understanding of clinical research methodology and biostatistical principles
• Advanced clinical specialty training with board qualification/registration in Hepatology or equivalent higher specialty training (preferred)
• Familiarity or experience in MASH or ALD drug development, disease biology, therapeutic targets, and treatment landscape (preferred)
• Clinical research experience in hepatology, including clinical development planning and interventional study design (preferred)
• Experience with site-facing interactions and/or activities supporting medical affairs, patient advocacy groups, or external organizations (preferred)
• Experience engaging with regulators, payors, and prescribers in relevant markets (preferred)
• Experience integrating genetic data to inform clinical protocols (preferred)
• Ability to apply statistical and data visualization methods to interpret complex information and support decision-making (preferred)
• Experience using new digital tools and learning technologies to drive innovation (preferred)

Core Competencies

Demonstrates expertise in clinical development planning and execution, particularly in liver diseases, with a strong understanding of regulatory requirements and clinical trial methodologies. Capable of leading cross-functional teams and providing medical oversight while integrating innovative methodologies and digital tools.

Highest-signal resume keywords

• Medical Degree
• Clinical Drug Development Experience
• Regulatory Submissions (IND, NDA, BLA, MAA)
• Clinical Research Methodology
• Medical Oversight Activities

ATS Optimization Keywords

Hard Skills

• Clinical Development Planning
• Clinical Trial Execution
• Biostatistical Principles
• Clinical Study Protocols
• Regulatory Interactions
• Medical Monitoring
• Evidence Generation Activities
• Data Visualization Methods
• Interventional Study Design
• Hepatology Expertise

Soft Skills

• Collaboration
• Leadership
• Communication
• Strategic Thinking
• Problem-Solving

Certifications & Qualifications

• Board Qualification in Internal Medicine
• Board Qualification in Primary Care / Family Medicine
• Board Qualification in Hepatology (Preferred)

Industry Keywords

• ICH Guidelines
• FDA Requirements
• Clinical Research
• Pharmaceutical Industry
• Patient Advocacy Groups
• Regulatory Expectations
• MASH Drug Development
• ALD Drug Development
• Therapeutic Targets
• Treatment Landscape

Tools & Technologies

• Digital Tools
• Learning Technologies