Head of Clinical Development

What if… you could join an organization that creates, resources, and builds life sciences companies that invent breakthrough technologies in order to transform health care and sustainability?

Montai Therapeutics is a privately held, biotechnology company focused on harnessing AI to decode untapped diverse chemistry to develop breakthrough oral medicines that can address persistent unmet needs in chronic disease. With our CONECTA™ platform, Montai has built the world’s leading foundation models for decoding the complex language between nature’s bioactive chemistry and human biology – supercharging the drug discovery process with unprecedented optionality and predictability.

The company has curated and annotated a collection of over 1B Anthromolecules™ and Anthrologs™, which are derived from molecules humans have chronically consumed in food, supplements and herbal medicines. This has enabled efficient access to chemistry with vast untapped structural diversity and the potential to selectively and precisely modulate complex biology. Montai is rapidly advancing a pipeline of first-in-class oral medicines for validated biological pathways in inflammation and immunology – focused on biologic replacements and historically difficult to drug transcription factors.

We are looking for an experienced Head of Clinical Development, reporting to our Chief Scientific Officer, 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.

Specifically, the Head of Clinical Development will play a pivotal role in driving the successful transition of programs from research to early clinical development and will contribute to shaping the clinical strategies that span from candidate discovery to human proof‑of‑concept. As a leader of our clinical development strategy, this role is responsible for crafting and integrating clinical development plans in alignment with research, translational, nonclinical, regulatory and strategic priorities.

This individual will also ultimately oversee those responsible for supporting program operations, resource planning, and interactions with internal governance and external partners. This role is ideal for an experienced individual passionate about translating cutting‑edge science into innovative medicines through rigorous, thoughtful and collaborative development planning and execution.

• 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.
• Drive and/or oversee the design, execution, analysis, interpretation and reporting of clinical studies, both early and more advanced, in collaboration with R&D team members, 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 for early (clinical pharmacology, including first in human, DDI, proof of mechanism/concept) and/or more advanced clinical studies; may 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 site(s).
• Lead/author clinical portions of regulatory submissions and responses to regulatory agency questions; as appropriate, serve as a company representative for regulatory interactions.
• Identify and address development…