Director, Early Clinical Development - Immunology (MD)

Role Summary

Director, Early Clinical Development - Immunology (MD). Responsible for medical accountability and oversight of multiple early-phase clinical trials, leading medical strategy, and providing cross-functional medical expertise within the Immunology-focused early development program.

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
• Acts as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept, articulating development strategy and interpreting 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 and safety management education with Clinical Scientists
• Assesses serious adverse events in partnership with Worldwide Patient Safety and contributes to safety narratives
• Contributes to Study Delivery Team and supports protocol development and safety considerations
• Ensures GCP compliance and required training
• Establishes relationships with global Phase I centers
• Designs and develops clinical studies and research plans across asset strategy (first-in-human to biomarker-guided studies)
• Defines dose, schedule, indications, and patient selection in collaboration with Clinical Scientists and Development Teams
• Leads benefit/risk analyses for development protocols
• Supports execution of studies (site activation, enrollment, protocol adherence)
• Maintains strong medical/scientific reputation within disease area and stays current with literature
• Provides ongoing medical education to study teams and investigators
• Represents the department in Health Authority interactions and regulatory submissions

Qualifications

• Advanced degree(s): MD, MD/PhD (or equivalent); clinical expertise in a relevant therapeutic area
• Subspecialty fellowship training in applicable therapeutic area preferred
• 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry settings

Key Competency Requirements

• Clear scientific and clinical communication and presentation skills
• Strong analytical ability for clinical data interpretation
• Knowledge of drug development processes and clinical planning
• Leadership and teamwork capabilities

Travel

• Domestic and international travel may be required