Head of Clinical Development

Position Summary

We are looking for an experienced Head of Clinical Development, reporting to our CEO, to have overall accountability for the development and implementation of small molecule clinical programs in the therapeutic areas of immunology/inflammation at Montai Therapeutics. We are seeking a highly motivated, collaborative, results-oriented individual with the creativity, resourcefulness, and flexibility to excel in our growing organization.

Key Responsibilities

• Develop programmatic clinical strategy; oversee implementation of clinical programs in line with the clinical strategy and ensure patient safety and data integrity
• Collaborate closely with Project Leaders, Research, Leadership, and External Advisors/KOLs to define and refine clinical hypotheses and development strategies
• Integrate clinical plans with translational, nonclinical, and regulatory development strategies to enable seamless progression from exploratory studies to FIH trials
• In collaboration with R&D colleagues, drive and/or oversee the design, execution, analysis, interpretation, and reporting of early stage and more advanced clinical studies in a matrixed and highly collaborative team environment
• Incorporate regulatory input, operational feasibility, and real-world data to ensure robust and executable development strategies
• Serve as a Medical Monitor (to include clinical pharmacology, including first in human, DDI, proof of mechanism/concept) for early and possibly more advanced clinical studies; serve as Project Team Leader for clinical stage programs
• Assess trade-offs and build alignment with team members to enable informed programmatic decision-making
• Support development and implementation of program biomarker plans and ensure successful implementation at study sites
• Lead/author clinical portions of regulatory submissions and responses to regulatory agency questions; as appropriate, serve as a company representative for regulatory interactions
• Proactively identify and address development risks and bottlenecks, drive resolution across functional interfaces
• Oversee growing internal and external clinical operations functions and support, including cross-functional leadership and collaboration with quality, CROs, regulatory, and medical writing teams

Required Experience

• MD or MD, PhD with at least 8+ years of relevant experience in the biopharmaceutical industry, including significant small molecule drug development work
• Broad understanding of biopharmaceutical drug development, including working knowledge of relevant ICH and GCP guidelines and regulations
• Prior experience as a functional leader (e.g., early clinical development, clinical pharmacology, translational/ experimental medicine)
• Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations is desirable
• Experience delivering effective presentations to both technical and non-technical audiences
• Proven leadership skills, with the ability to collaborate and convey strategic implications to diverse stakeholders
• History of attracting, retaining, and developing world-class talent
• Strong strategic thinking and critical thinking skills for identifying and addressing bottlenecks while optimizing cross-functional processes
• Proactive and adaptable in demanding environments, with an operational mindset to improve efficiency and achieve strategic goals

Desired Skills & Competencies

• Excellent written and oral communication skills
• Experience delivering effective presentations to both technical and non-technical audiences
• Proven leadership skills, with the ability to collaborate and convey strategic implications to diverse stakeholders.
• Strong strategic thinking and critical thinking skills for identifying and addressing bottlenecks while optimizing cross-functional processes.
• Proactive and adaptable in demanding environments, with an operational mindset to improve efficiency and achieve strategic goals.