The DMPK team seeks an experienced Scientist/ Sr. Scientist to provide DMPK/ Clinical Pharmacology support to the research and development team. The ideal candidate will be highly skilled in conducting DMPK studies and data interpretation, and characterization of the Axcella products. He or she will serve as a DMPK representative in interdisciplinary collaborations and communicate conclusions, progress, and plans at internal meetings. Hands-on PK/TK analysis, PK/PD, PB/PK or other modeling technique is highly desirable.
Key tasks and responsibilities
Incorporate DMPK modeling and simulation capabilities in planned clinical studies
Independently design, execute and interpret DMPK studies (preclinical and clinical) to investigate PK/PD of AXA amino acids
Assist in the management of external DMPK (preclinical and clinical) and Toxicology studies by providing tactical resolutions to scientific challenges
Contribute to PK/PD sections of clinical study protocols and regulatory documents (e.g. IB and IND)
Study execution and documentation under GxP environment (PK/TK analysis)
Skills and attributes
Hands-on PK/TK, PK/PD and PB/PK analysis and prediction using diverse modeling techniques (Phoenix, G+, Simcyp, R, NONMEM, etc.)
Highly motivated individual with a strong intellectual and technical background in DMPK/Clinical Pharmacology discipline
Proven ability to independently perform high quality research and work effectively on multifunctional teams
Experience in the conduct of early clinical studies from PK perspective is highly desired
Excellent problem-solving abilities
Excellent written and oral communication skills
Education and Experience
Degree in drug metabolism, biochemistry, pharmacokinetics, pharmacology or related field. PhD with up to 5 years, or MS with 8+ years of experience in a pharmaceutical industry setting. Experience in early clinical PK study conduct and/or modeling/simulation strategies is highly desired
About Axcella Health
Axcella is combining endogenous metabolic modulators to develop powerful new medicines with the goal of addressing metabolic dysregulation by safely reprogramming cellular physiology with unprecedented multifactorial effects. Our AXA™ product candidates are designed to leverage the diversity and synergy of amino acid biology and target restoring health across a network of dysregulated pathways.
We are committed to researching and developing groundbreaking treatments for patients with unmet needs. Our AXA candidates are designed, optimized and studied using our platform. This innovative paradigm integrates preclinical studies and data from our human signal seeking and confirming studies* in a rapid, iterative process to generate candidates with a higher probability of success. Our platform has already produced a rich pipeline of multifunctional product candidates including programs in liver, muscle, CNS and other indications.