Director, Early Clinical Development - Immunology (MD)

Role Summary

Director, Early Clinical Development - Immunology

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 by
• Articulating clinical development strategy
• Analyzing, interpreting, and acting on clinical trial data to support development
• Serving 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 (including safety management guidelines)
• 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 (input on inclusion/exclusion and other safety-related clinical considerations)
• 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 in support of asset strategy with the Early Clinical Development Leadership team; clinical studies include first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, biomarker qualification studies, and/or clinical pharmacology studies
• Liaises with Clinical Scientists, Translational & Discovery Scientists and Development Teams to define dose and schedule, indications, and patient selection (e.g., biomarker qualification and implementation)
• Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working with Clinical Scientists
• Partners with Clinical Scientists to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
• Maintains a strong medical/scientific reputation within the disease area; has in-depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder
• Keeps up to date in the disease area by attending scientific conferences and ongoing review of the literature
• Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
• Provides ongoing medical education in partnership with Clinical Scientists to allow for protocol-specific training, supporting the study team, investigators, and others
• Ad-Hoc involvement in various departmental initiatives (e.g., committees, sub-teams etc.)
• Presents and/or articulates clinical strategy to senior leadership and to support progression of portfolio

• Health Authority Interactions
• Contributes to key Health Authority interactions and advisory board meetings as Early Clinical Development Physician; serves as Primary Clinical Representative in Regulatory interactions for early development projects
• Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study in partnership with Clinical Scientists

• External Partnerships, Alliances, and Publications
• Sits in team responsible for establishing key alliances with academic centers, co-operative groups, vendors and government agencies
• Represents department in business development due diligence and partner alliance management with oversight
• Acts as a focal point for defining and establishing relationships with key global Phase 1 Centers
• Track record or recognized for contributions to field (e.g., publications, patents, keynote participation in conferences etc.)

• Education
• Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent)
• 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 setting including education where applicable

• Key Competencies
• Ability to communicate and present information clearly in scientific and clinical settings
• Expertise in the scientific method to test hypotheses, including statistical design, analysis, and interpretation
• Knowledge of drug development process
• Knowledge of the components needed to execute an effective clinical plan and protocols
• Strong leadership skills with proven ability to lead and work effectively in a team environment

• Travel
• Domestic and International travel may be required

Education

• Advanced degree(s) in relevant field: MD, MD/PhD (or x-US equivalent) and clinical expertise in a therapeutic area (e.g., attending level or international equivalent)
• Subspecialty fellowship training in applicable therapeutic area preferred

Qualifications

• 5+ years of relevant experience in discovery, translational and/or clinical research in academic or industry setting including education where applicable