Key Responsibilities

• Formulate and execute the global clinical development strategy for novel TB drug candidates
• Lead and mentor a diverse team of medical, operational, and safety professionals
• Oversee the design and execution of efficient, scientifically sound clinical trials
• Manage relationships with regulatory authorities to expedite product approvals
• Collaborate with research teams to ensure smooth transitions from lead selection to clinical proof-of-concept

Essential

• Extensive experience in clinical development strategy and implementation
• Proven track record in leading Phase 1 through Phase 4 clinical trials
• Experience managing regulatory interactions with the FDA and international bodies
• Expertise in pharmacovigilance and drug safety compliance
• Ability to integrate nonclinical and clinical activities into robust development plans
• Experience in managing medical affairs and clinical operations functions
• Ability to represent the organization to external stakeholders, including funders and scientific communities

Preferred

• Specific experience in tuberculosis or infectious disease drug development
• Experience conducting clinical trials in TB endemic regions
• Background in developing multidrug regimens
• Experience with biomarker strategy and IND-enabling studies

Key Skills