Director, Early Clinical Development - Immunology (MD)

Role Summary

Director, Early Clinical Development - Immunology. Lead medical accountability across multiple early-stage trials, guide clinical strategy, and provide cross-functional medical expertise within the Early Clinical Development - Immunology function.

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
• Author for regulatory submissions, study reports, and publications
• Provides oversight and medical accountability for multiple trials across the early development lifecycle
• Manages site interactions with the Clinical Scientist for medical questions and education
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and contributes to safety narratives
• Contributes to Study Delivery Team and may participate in Development Team activities
• Collaborates with Clinical Scientists on protocol development and safety-related considerations
• Fulfills GCP and compliance obligations and maintains required training
• Defines and establishes relationships with key global Phase I Centers
• Works on multiple trials across early development lifecycle
• Designs and develops clinical studies and research plans in support of asset strategy for first-in-human, proof-of-concept, and other early-stage studies
• Liaises with Clinical Scientists and Development Teams to define dose, schedule, indications, and patient selection
• Leads benefit/risk analysis for clinical development protocols in a matrix environment
• Supports execution of studies including site activation and enrollment, and adjudication of protocol deviations
• Maintains strong medical/scientific reputation in the disease area and stays current with literature
• Provides ongoing medical education for protocol-specific training
• Presents clinical strategy to senior leadership to support portfolio progression

Qualifications

• Advanced degree(s) in relevant field: MD, MD/PhD (or equivalent)
• 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
• Travel: Domestic and international travel may be required

Skills

• Clear scientific and clinical communication and presentation
• Expertise in scientific methods, including study design, analysis, and interpretation
• Knowledge of the drug development process and clinical plan execution
• Leadership and ability to work effectively in a team

Education

• MD or MD/PhD with clinical expertise; subspecialty training preferred

Additional Requirements

• Compliance with GCP and regulatory requirements
• Ability to collaborate with internal and external stakeholders and maintain relationships with global centers