Head of Clinical Development

Head Of Clinical DevelopmentWhat 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.Key Responsibilities:Develop programmatic clinical strategy; oversee implementation of clinical programs in line with the clinical strategy and ensure patient safety and data integrityCollaborate 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 environmentIncorporate 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 programsAssess trade-offs and build alignment with team members to enable informed programmatic decision-makingSupport 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 interactionsIdentify 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.Required Experience:M.D. or M.D., Ph.D. with 8+ years of relevant experience in biopharmaceutical industry, including significant small molecule drug development experienceEducational 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/inflammationPrior 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 regulationsProficiency 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 functionsRecord of significant and successful contributions to regulatory submissions, including INDs/CTAs, and regulatory agency interactionsExperience managing collaborations with consultants, pharmaceutical partners, CROs, and other external organizations is desirableAptitude in serving as a subject matter expert and mentor across the organizationDesired Skills & Competencies:Excellent written and oral communication skillsExperience delivering effective presentations to both technical and non-technical audiencesProven 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, MAMore About Flagship PioneeringFlagship 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).Flagship Pioneering and our ecosystem companies are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.Recruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, "FSP") do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering's internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.