Head of Clinical Development

Responsibilities

• Develop and implement programmatic clinical strategies for small molecule programs in immunology and inflammation
• Oversee the execution of clinical programs to ensure patient safety and data integrity
• Collaborate with Project Leaders, Research, and external KOLs to refine clinical hypotheses and development strategies
• Integrate clinical plans with translational, nonclinical, and regulatory development strategies
• Serve as a Medical Monitor for early-stage and advanced clinical studies, including first-in-human and proof-of-concept trials
• Lead and author clinical portions of regulatory submissions (IND/CTA) and manage interactions with regulatory agencies
• Oversee clinical operations, including management of CROs, quality, and medical writing teams
• Proactively identify and address development risks and bottlenecks across functional interfaces

Requirements

• MD or MD, PhD degree
• 8+ years of biopharmaceutical industry experience with significant small molecule drug development expertise
• Strong educational or industry background in immunology and inflammation
• Proven experience with ICH and GCP guidelines and regulations
• Demonstrated success in regulatory submissions, including IND or CTA filings
• Experience as a functional leader in early clinical development, clinical pharmacology, or translational medicine
• Excellent written and oral communication skills with the ability to present to technical and non-technical audiences

Preferred Qualifications

• Experience managing collaborations with pharmaceutical partners, consultants, and CROs
• Proven track record of attracting, retaining, and developing high-performing scientific talent
• Ability to thrive in a fast-paced, demanding, and highly collaborative matrixed environment

Benefits

• Healthcare coverage
• Annual incentive program
• Retirement benefits

About the Company

Montai Therapeutics is a biotechnology company focused on harnessing AI to decode untapped diverse chemistry to develop breakthrough oral medicines for chronic diseases. Using our CONECTA™ platform, we build foundation models to decode the complex language between bioactive chemistry and human biology, advancing a pipeline of first-in-class medicines for inflammation and immunology.