Executive Director, Clinical Development Program Lead, Hematology
9 days ago
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, • 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 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. • MD, • Clinical Trial Management, • Regulatory Submissions, • Phase I, II, III Clinical Trials, • Leadership and Team Development, • 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, • Mentoring, • Collaboration, • Communication, • Relationship Building, • Ethical Leadership, • MD, • PhD (Optional), • Clinical Development, • Drug Development, • Regulatory Compliance, • Clinical Excellence, • Lifecycle Management, • Global Experience, • Matrix Management, • Thought Leader Engagement, • Patient Advocacy, • Governance Participation #J-18808-Ljbffr