Head of Clinical Development

Flagship Pioneering•Cambridge, MA

12d•Onsite

About The Position

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. Position Summary: 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.

Requirements

M.D. or M.D., Ph.D. with 8+ years of relevant experience in biopharmaceutical industry, including significant small molecule drug development experience
Educational background in a relevant scientific discipline (e.g., biology, biochemistry, immunology) and advanced degree(s), including as Doctor of Medicine and post-graduate medical or scientific training; specific therapeutic experience in immunology/inflammation
Prior experience as a functional leader (e.g., early clinical development, clinical pharmacology, translational/experimental medicine)
Broad understanding of biopharmaceutical drug development, including working knowledge of relevant ICH and GCP guidelines and regulations
Proficiency in developing and nurturing key partnerships and collaborations with external parties, including investigators, KOLs, CROs, and the broader scientific community (including academia, governmental, or nonprofit organizations), as well as internal discovery and preclinical functions
Record of significant and successful contributions to regulatory submissions, including INDs/CTAs, and regulatory agency interactions
Experience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations is desirable
Aptitude in serving as a subject matter expert and mentor across the organization
Excellent written and oral communication skills
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.

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.
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 risks and bottlenecks proactively; drive resolution across functional interfaces.
Oversight of growing internal and external clinical operations functions and support, including cross-functional leadership and collaboration with quality, CROs, regulatory, and medical writing teams.