Director, Early Clinical Development - Immunology (MD)

Role Summary

Director, Early Clinical Development - Immunology (MD) responsible for medical accountability across multiple early clinical trials, overseeing Phase I/II studies, and providing medical and scientific leadership within a cross-functional team.

Responsibilities

• Serves as a primary source of medical accountability and oversight for multiple clinical trials
• Manages Phase I/II studies, with demonstrated decision making capabilities
• Provides medical and scientific expertise to cross-functional colleagues
• Maintains matrix management responsibilities across internal and external networks

Medical Monitoring

• Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept
• Articulates clinical development strategy; analyzes and interprets trial data; authors regulatory submissions, study reports, and publications
• Provides oversight and medical accountability for multiple trials across the early development lifecycle
• Manages site interactions with Clinical Scientist for medical questions and safety education
• Assesses key safety-related events in partnership with Worldwide Patient Safety; contributes to safety narratives
• Contributes to Study Delivery Teams and may participate in Development Team
• Collaborates with Clinical Scientists on protocols and safety-related considerations
• Fulfills GCP and training requirements
• Establishes relationships with global Phase I Centers

Clinical Development Expertise & Strategy

• Designs and develops clinical studies and research plans for asset strategy across various study types
• Defines dose, schedule, indications, and patient selection in collaboration with scientists
• Leads benefit/risk analysis for protocols in a matrix team
• Supports execution of studies (site activation, enrollment, protocol adherence)
• Maintains strong medical reputation; stays informed on disease etiology and treatment
• Keeps up to date with literature and regulatory issues; provides medical education to study teams
• Participates in departmental initiatives; presents clinical strategy to leadership

Health Authority Interactions

• Contributes to Health Authority interactions and advisory boards as Early Clinical Development Physician
• Authors clinical content for CSRs, regulatory reports, briefing books, and submissions

External Partnerships, Alliances, and Publications

• Establishes alliances with academic centers, cooperative groups, vendors, and government agencies
• Represents department in due diligence and partner alliance management
• Acts as focal point for relationships with global Phase 1 Centers
• Track record of contributions to the field (publications, patents, conference involvement)

Education

• Advanced degree: MD, MD/PhD or equivalent; clinical expertise in a therapeutic area
• Subspecialty fellowship training preferred

Experience

• 5+ years of relevant experience in discovery, translational, and/or clinical research in academic or industry settings

Key Competencies

• Clear communication and presentation in scientific/clinical settings
• Strong scientific method and statistical design/analysis
• Knowledge of the drug development process and clinical plan execution
• Leadership and teamwork capabilities

Travel

• Domestic and international travel may be required