Director, Early Clinical Development - Immunology (MD)

Role Summary

Director, Early Clinical Development - Immunology (MD).

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 BMS 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, interprets, and acts on clinical trial data to support development
• Serves as principal functional author for Regulatory submission, study reports, and publications
• Provides oversight and medical accountability for multiple trials across early development clinical lifecycle
• Manages site interactions in partnership with the Clinical Scientist for medical questions and education
• Assesses key safety-related serious adverse events in partnership with Worldwide Patient Safety and oversees contributions to safety narratives
• Contributes to and is a key member of a high performing Study Delivery Team (SDT) and may be a member of the Development Team
• Collaborates with Clinical Scientists and provides input into protocols, contributing medical strategic oversight in protocol development
• Fulfills GCP and compliance obligations for clinical conduct and maintains all required training
• Acts as a focal point for defining and establishing relationships with key global Phase I Centers
• Works on multiple trials across early development clinical lifecycle
• Clinical Development Expertise & Strategy: designs and develops clinical studies and research plans; biomarker qualification studies; and/or clinical pharmacology studies
• Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose, schedule, indications, and patient selection
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment
• Partners with Clinical Scientists to support executional delivery of studies (site activation, enrollment status, adjudication of deviations)
• Maintains a strong medical/scientific reputation within the disease area; stays current with etiologies and treatments
• Provides ongoing medical education to study teams, investigators, and others
• Presents and/or articulates clinical strategy to senior leadership to support portfolio progression
• Health Authority Interactions: contributes to key Health Authority interactions and advisory board meetings; primary Clinical Representative in Regulatory interactions for early development projects
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents
• External Partnerships, Alliances, and Publications: establishes alliances with academic centers, cooperative groups, vendors and government agencies; represents department in due diligence and partner management
• Act as a focal point for establishing relationships with key global Phase 1 Centers; track record of contributions to the field

Qualifications

• Advanced degree in relevant field: MD, MD/PhD (or equivalent); clinical expertise in a 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
• Strong leadership and ability to lead and work effectively in a team environment

Skills

• Clear communication and presentation in scientific/clinical settings
• Expertise in the scientific method, including statistical design, analysis, and interpretation
• Knowledge of the drug development process and clinical planning
• Ability to manage multiple trials and cross-functional collaboration
• Medical monitoring and regulatory writing capabilities

Education

• MD or MD/PhD (or international equivalent) required

Additional Requirements

• Travel: Domestic and international travel may be required