Clinical Trial Program Lead

• Lead the creation and execution of exploratory and biopharmaceutics clinical development plans at the molecule level
• Provide technical leadership and operational oversight for clinical research trials
• Plan and deliver clinical molecules and submission milestones on time and on budget throughout the molecule lifecycle
• Manage global clinical trial operations from trial design through execution and closeout
• Create and manage timelines, outsourcing plans, vendor relationships, patient recruitment and retention, and budgets
• Lead Phase 1 clinical asset strategy and advise on clinical and regulatory documents
• Stay current on disease knowledge, competitors, and industry trends
• Lead clinical project management processes and tools
• Collaborate with TPOs to execute clinical strategy and oversee trial outcomes
• Identify and communicate clinical risks and mitigation plans
• Oversee clinical trial planning and execution to meet timelines and budgets
• Select and manage vendors and resolve operational issues
• Partner with regulatory and medical teams on safety processes
• Lead clinical team interactions and governance participation
• Communicate across levels and functions to support decision-making
• Mentor colleagues and provide constructive feedback

• Bachelor’s degree in a science related field
• Few years of experience in the pharmaceutical industry managing clinical studies
• Few years of experience managing Phase 1 studies, including exploratory and biopharmaceutics clinical development
• Experience with vendor and contract management
• Proficiency in end-user computing and Microsoft Office (Word, Excel, PowerPoint, Project)
• Strong knowledge of clinical trial regulations and guidelines
• Experience managing TPOs to ensure trial deliverables
• Experience with project management tools and methodologies
• Willingness to travel up to 10%
• Ability to mentor and develop others
• Ability to work effectively in cross-cultural and virtual team environments
• Strong leadership and networking capabilities
• Root cause analysis and problem-solving skills
• Effective time management and adaptability to diverse stakeholders
• Clear written and verbal communication skills
• Ability to influence and build strong internal and external relationships

Demonstrates expertise in leading clinical development plans and managing Phase 1 clinical studies, with a strong focus on project management, vendor relationships, and regulatory compliance. Proven ability to mentor teams and communicate effectively across diverse stakeholders.

• Clinical Development Leadership
• Phase 1 Study Management
• Vendor Management
• Project Management Tools
• Clinical Trial Regulations

• Clinical Trial Management
• Biopharmaceutics Development
• Regulatory Document Preparation
• Budget Management
• Patient Recruitment Strategies
• Timeline Creation
• Risk Mitigation Planning
• Root Cause Analysis
• Microsoft Office Suite
• Project Management Methodologies

• Leadership
• Mentoring
• Effective Communication
• Problem-Solving
• Adaptability

• Pharmaceutical Industry
• Clinical Research Trials
• Exploratory Studies
• Cross-Cultural Teamwork
• Clinical Governance

• Project Management Tools
• End-User Computing