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 Carolina and references 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

 

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 studies
• Interact and oversee outsourcing ADME/PK studies as a study monitor
• Prepare, review, and approve GLP/non-GLP-related documents (SOPs, protocols, amendments, reports, etc.) generated internally or externally
• Assist 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 goals 
• Serve 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 activities
• Oversee ADME/PK data entry to internal database

 

Qualifications: 

• 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/ guidelines
• Depth understanding bioanalysis with LC/MS/MS (or HRMS), data interpretation and troubleshooting
• Strong 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.