Director, Early Clinical Development - Immunology (MD)

Role Summary

Director, Early Clinical Development - Immunology (MD) overview of medical accountability and leadership for early clinical trials within the Immunology function, focusing on Phase I/II study design, execution, and strategy to select promising candidates for later development.

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
• Serves as an independent Medical Monitor for clinical trials from Phase 1 through Proof-of-Concept, articulating strategy, interpreting data, and supporting development
• Author for Regulatory submissions, study reports, and publications
• Provides oversight and medical accountability for multiple trials across early development lifecycle
• Manages site interactions with Clinical Scientist for medical questions and education
• Assesses serious safety events in partnership with Worldwide Patient Safety and contributes to safety narratives
• Contributes to a high performing Study Delivery Team and may participate in Development Team
• Collaborates with Clinical Scientists and contributes to protocol development, including inclusion/exclusion and safety considerations
• Fulfills GCP and compliance obligations and maintains required training
• Establishes relationships with key global Phase I Centers
• Works on multiple trials across early development lifecycle

Clinical Development Expertise & Strategy

• Designs and develops clinical studies and research plans in support of asset strategy, including first-in-human Phase I and early Phase I/II studies, biomarker qualification, and pharmacology studies
• Liaises with Clinical Scientists and Development Teams to define dose, schedule, indications, and patient selection
• Leads benefit/risk analysis for development protocols within a matrix team
• Supports execution of studies (site activation, enrollment status, adjudication of deviations)
• Maintains strong medical/scientific reputation in the disease area and keeps up to date with literature
• Monitors regulatory issues and portfolio fit within competitive landscape
• Provides medical education to study teams and investigators
• Participates in departmental initiatives and communicates clinical strategy to senior leadership

Health Authority Interactions

• Contributes to Health Authority interactions and advisory board meetings as Early Clinical Development Physician
• Authors 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 alliance management
• Acts as focal point for relationships with global Phase 1 Centers
• Track record of contributions to the field (publications, patents, conference participation)

Education

• MD or MD/PhD (or equivalent) with clinical expertise in a therapeutic area
• Subspecialty fellowship training in applicable therapeutic area 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 and clinical settings
• Strong analytical skills, including statistical design and interpretation
• Knowledge of the drug development process
• Ability to execute an effective clinical plan and protocols
• Leadership and collaboration within a team environment

Travel / Physical Requirements

• Domestic and international travel may be required