Montai Therapeutics · 11 hours ago
Head of Clinical Development
Cambridge, MA
Full-time
Onsite
Director/Executive
$360K/yr - $415K/yr
8+ years expMontai Therapeutics is a privately held biotechnology company focused on harnessing AI to develop breakthrough oral medicines. The Head of Clinical Development will be responsible for the development and implementation of small molecule clinical programs in the therapeutic areas of immunology/inflammation, ensuring patient safety and data integrity while overseeing clinical strategies.
Health CareMedical
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
Qualification
Required
M.D. or Ph.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
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
Benefits
Healthcare coverage
Annual incentive program
Retirement benefits
Broad range of other benefits
Company
Montai Therapeutics
Montai Health platform enables rapid and repeatable advancement of therapies across multiple diseases.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$50MKey Investors
Flagship Pioneering
2022-12-13Series A· $50M
Leadership Team
Margaret Georgiadis
Co-Founder and CEO, Montai Therapeutics
Recent News
2025-11-03
2025-10-28
Company data provided by crunchbase