Principal Scientist, DMPK Cambridge, MA

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 Health is a privately held, early-stage biotechnology company developing a platform for understanding and leveraging complex molecular interactions within organisms to solve global challenges in human health and sustainability. The company leverages a multidisciplinary approach that integrates tools ranging from machine learning and big data to multi-omics and high-throughput screening.At Montai, we nurture a bold, spirited and leading-edge culture dedicated to strengthening human health:We are one team with omnidirectional trust, empowered and accountableWe are strong as individuals but stronger as a team and we are committed to excellenceWe have a sense of urgency and persistence and we are crazily confident that we can make a differenceWe need to be comfortable with the uncomfortable and be rigorous and we recognize that failure is dataWe care for diversity in people, thought, personality, opinions, background and distinctivenessWe have a sense of humor to help us manage through our strategic noisePosition Overview:Reporting to the Head of DMPK at Montai Therapeutics, the ideal candidate will lead DMPK activities to support research and early development projects in Montai Therapeutics’ Drug Metabolism and Pharmacokinetics (DMPK) team. We expect this person to collaborate with team members across other functions such as medicinal chemistry, formulation, safety assessment, pharmacology and clinical development to advance Montai’s pipeline. We also would expect the ideal candidate to design and manage external ADME/PK studies at multiple contract research organizations.Responsibilities:Initiate and conduct in vitro and in vivo ADME/PK studiesInteract and oversee outsourcing ADME/PK studies as a study monitorPrepare, review, and approve GLP/non-GLP-related documents (SOPs, protocols, amendments, reports, etc.) generated internally or externallyAssist the Head of DMPK department in establishing a solid research and development system and in prioritizing and forecasting workload, and ultimately meeting group, departmental, and company goalsServe as a project team representative: Ensure effective achievement of lead optimization goals and candidate selection in late-stage research. Coordinate and interact with other department members for planning GLP or non-GLP nonclinical studies, clinical studies, TK/safety, and DMPK-related activitiesOversee ADME/PK data entry to internal databaseQualifications:Advanced degree required in pharmacology and ADME/PK related discipline with a minimum of 10 years of relevant experience in DMPK and/or relevant experience.Depth understanding of Pharmacology/ADME/PK and GLP regulations and relevant regulatory guidance/guidelinesDepth understanding bioanalysis with LC/MS/MS (or HRMS), data interpretation and troubleshootingStrong communication and interpersonal skills. Also, ability to present complex data to scientific and non-scientific members.Hands-on experience with WinNonlin/Phoenix. Experience in simulation software (e.g. PBPK simulator) is a plus.Flagship Pioneering has conceived of and created companies such as Moderna Therapeutics (NASDAQ: MRNA), Editas Medicine (NASDAQ: EDIT), Omega Therapeutics (NASDAQ: OMGA), Seres Therapeutics (NASDAQ: MCRB), and Indigo Agriculture. Since its launch in 2000, Flagship has applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures. In 2021, Flagship Pioneering was ranked 12th globally on Fortune’s “Change the World” list, an annual ranking of companies that have made a positive social and environmental impact through activities that are part of their core business strategies.Flagship Pioneering and our ecosystem companies are

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