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 worlds leading foundation models for decoding the complex language between natures 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 Executive 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 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.

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
• Educational and/or industry background in immunology and 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 or 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
• Clear and 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
• 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.

Location: Cambridge MA

More About Flagship Pioneering

Flagship Pioneering conceives creates resources and develops first-in-category life sciences companies to transform human health and sustainability. Since its launch in 2000 the firm has through its Flagship Labs unit applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures resulting in over $50B in aggregate value. To date Flagship has deployed over $2.2B in capital toward the founding and growth of its pioneering companies alongside more than $18B of follow-on investments from other institutions. The current Flagship ecosystem comprises 41 transformative companies including Axcella Health (NASDAQ: AXLA) Denali Therapeutics (NASDAQ: DNLI) Evelo Biosciences (NASDAQ: EVLO) Foghorn Therapeutics (NASDAQ: FHTX) Indigo Ag Kaleido Biosciences (NASDAQ: KLDO) Moderna (NASDAQ: MRNA) Rubius Therapeutics (NASDAQ: RUBY) Sana Biotechnology Seres Therapeutics (NASDAQ: MCRB) and Sigilon Therapeutics (NASDAQ: SGTX).