Executive Director, Clinical Development Program Lead, Hematology in Uxbridge

• Set the clinical development strategy for assets or indications
• Directly supervise Clinical Development Leads and oversee Clinical Trial Physicians
• Supervise broad Clinical Development and Disease/Indication Strategy teams
• Work with Research and Early Development and Global Drug Development to support transitions and benefit-risk assessments
• Supervise differentiated Clinical Development Programs from Phase I expansion through registrational execution
• Support Clinical Excellence activities, Protocol Review Committee, business development and Quality and Compliance leadership
• Report to the Head of Clinical Development and deputize as required
• Create and communicate innovative clinical development plans
• Supervise development, monitoring, analysis and interpretation of clinical trials
• Oversee clinical components of regulatory filings
• Contribute to disease/indication and franchise portfolio strategy
• Lead business development due diligence search and evaluation activities
• Serve on and chair Therapeutic Area Clinical Development Leadership forums
• Develop programs beyond commercialization and launch into lifecycle management
• Lead, recruit, develop and retain Clinical Development professionals
• Mentor talent and establish an ethical, collaborative and accountable culture
• Oversee team budget and headcount
• Collaborate globally with Research, Development, Regulatory, Medical, Commercial and other functions
• Build relationships with thought leaders, physicians and patient advocacy groups
• Ensure seamless transition from first-in-human and proof-of-concept trials into Phase II–III development
• Participate in governance as designated
• Exercise signature authority for CSRs, Health Authority Briefings, DMC Charters, Unblinding Requests and filing documents

Requirements

• MD required
• PhD or other high level degree optional
• Greater than 12 years of extensive clinical trial, drug development, and regulatory experience
• Management experience required
• Strong scientific background
• Extensive experience designing and conducting Phase I, II and III clinical trials
• Demonstrable success filing regulatory dossiers and prosecuting them through approval
• Global experience is a plus
• Experience interacting with business development and licensing
• Proven track record managing complex clinical programs leading to regulatory submissions
• Deep understanding of biology, targets and translational science
• Extensive experience working with health authorities at all levels
• Ability to support and manage registrational and non-registrational trials
• Ability to execute the BMS R&D People Strategy and lead and develop a matrix team
• Ability to work with Commercial, Medical, and research functions from Research through Regulatory
• Comfortable with cross-functional drug and product development teams and managing in a matrix environment
• Skilled at external interaction and speaking engagements
• Skilled at attracting, developing and retaining skilled professionals
• Domestic and international travel may be required

Core Competencies

Demonstrates extensive expertise in clinical trial design and execution, with a strong focus on regulatory submissions and compliance. Proven ability to lead and develop cross-functional teams while fostering collaboration and ethical practices in clinical development.

Highest-signal resume keywords

• MD
• Clinical Trial Management
• Regulatory Submissions
• Phase I, II, III Clinical Trials
• Leadership and Team Development

Hard Skills

• Clinical Development Strategy
• Clinical Trial Design
• Regulatory Filings
• Data Monitoring and Analysis
• Disease/Indication Strategy
• Business Development Evaluation
• Budget Management
• Translational Science
• Complex Program Management
• Health Authority Interaction

Soft Skills

• Mentoring
• Collaboration
• Communication
• Relationship Building
• Ethical Leadership

Certifications & Qualifications

• MD
• PhD (Optional)

Industry Keywords

• Clinical Development
• Drug Development
• Regulatory Compliance
• Clinical Excellence
• Lifecycle Management
• Global Experience
• Matrix Management
• Thought Leader Engagement
• Patient Advocacy
• Governance Participation