Principal Scientist, DMPK

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 accountable
• We are strong as individuals but stronger as a team and we are committed to excellence
• We have a sense of urgency and persistence and we are crazily confident that we can make a difference
• We need to be comfortable with the uncomfortable and be rigorous and we recognize that failure is data
• We care for diversity in people, thought, personality, opinions, background and distinctiveness
• We have a sense of humor to help us manage through our strategic noise

Montai is seeking a highly motivated and experienced DMPK scientist to support our Drug Development team and play an important role in the company’s efforts to validate novel discovery approaches based on AI/ML platform.

This individual will report to the Sr. Director, DMPK. The successful candidate will have deep experience in small molecule drug development and will help drive DMPK focused support activities to enable quality drug candidates to become transformative medicines for serious diseases.

Key Responsibilities: 

• Provide subject matter expertise on absorption, distribution, metabolism, and excretion (ADME) and pharmacokinetic-pharmacodynamic (PK-PD) modeling in support of Discovery projects
• Serve as a DMPK representative. Coordinate and interact with other department members for planning GLP and/or non-GLP nonclinical studies, clinical studies, TK/safety, and DMPK-related activities
• Work as a principal investigator in dose formulation analysis and TK/PK analysis
• Ensure effective achievement of lead optimization and candidate selection in late-stage research
• Assist the DMPK Department Head in establishing solid research and clinical development systems; ensuring the scientific quality of the experimental data
• Assist the DMPK Department Head in prioritizing workload, forecasting growth needs, and ultimately meeting group, departmental, and company goals 
• Monitor laboratory workload and resource allocation 
• Prepare, review, and approve GLP/non-GLP-related documents (SOPs, protocols, amendments, reports, etc.) generated internally or externally
• Interact and oversee outsourced studies as a study monitor

Required Qualifications: 

• D. with an understanding of GLP regulations and relevant FDA guidelines and 8+ years’ experience in DMPK labs
• Hands-on analytical skills with HPLC and LC/MS (HRMS), data interpretation, and troubleshooting skills for bioanalytical equipment and method development.
• Demonstrated problem-solving skills, critical/strategic thinking ability, and capability of integrating data across multiple sources are required
• Hands-on experience in conducting in vitro and/or in vivo experiments is required;
• Strong communication skills, good interpersonal skills and strong data presentation skills in addition to the ability to work and collaborate well in a cross-functional team setting are critical for this role

Preferred Qualifications: 

• Experience in modeling and simulation and/or in silico approaches
• Management experience within interacting with CROs
• Hands-on experience with WinNonlin/Phoenixand simulation software (e.g., Simulation Plus or SymCyp)

More About Flagship Pioneering

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 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.