Associate Director/Director/Sr Director, DMPK

Volastra Therapeutics, Inc. is a biotechnology company based in New York City, formed from the laboratory of Dr. Lewis Cantley, along with Drs. Olivier Elemento and Samuel Bakhoum.  Volastra is dedicated to the discovery and development of treatments for patients with cancer.  The Company’s therapies will target novel pathways and apply insights gained from its scientific founders into chromosomal instability (CIN) and its clear association with the formation, progression, and maintenance of disease.  Our lead program, a KIF18A inhibitor, is on track to enter the clinic in the second half of 2023 for patients with advanced cancer.

Volastra has raised funding from top US and European venture firms, including Vida, Polaris, Droia, and Arch. Volastra recently announced a multi-year up to $1.1B drug discovery collaboration with Bristol Myers Squibb leveraging Volastra’s proprietary CINtech platform to identify CIN-related targets. In addition, Volastra has a partnership with Microsoft to develop AI technologies for the interrogation of CIN.  The company has a world class advisory board including two Nobel Laureates as well as a highly experienced senior leadership team. The company operates out of 15,000 square feet of office and state-of-the-art laboratory space in West Harlem, New York City, within easy traveling distance of Columbia, Cornell, Memorial Sloan Kettering, and most other areas of the city, Westchester County, and New Jersey.

The Associate Director/Director/Senior Director of DMPK will report directly to the Vice President of Chemistry and work closely will partner with the Scientific Project Leaders to successfully shape and execute the relevant PK/ADME portions of the project to support the overall drug development strategies from early discovery through clinical development.  Job responsibilities will include, but are not limited to:

1. Serve as the DMPK subject matter expert for nonclinical development
2. Manage CROs in the conduct of in vitro/in vivo ADME and DMPK modeling studies
3. Prepare strategic, innovative, and scientifically sophisticated PK/ADME drug development strategies that meet regulatory requirements and program goals
4. Design, execute and interpret non-clinical pharmacology, toxicology, DMPK and translational studies supporting progression of therapies from early discovery through first in human and proof of concept clinical studies
5. Prepare high quality preclinical and translational DMPK work packages to support projects in lead optimization and clinical candidate selection as well as any associated regulatory filings
6. Design preclinical studies and report results to project teams to evaluate and optimize series and compounds towards a selected candidate with acceptable and predictable clinical PK properties and drug-drug interaction profile
7. Collaborate with scientific team and clinical development to characterize human pharmacokinetics, metabolism, and biopharmaceutics of clinical compounds
8. Assess and communicate DMPK results to senior management to support key go, no-go decisions
9. Build, manage and coach a team of high performing subject matter experts to support research and clinical programs, as needed

• Ph.D. degree in relevant scientific field and greater than 8 years’ experience with DMPK in drug discovery in a Pharmaceutical or Biotech setting, or M.Sc. degree and greater than 12 years relevant industrial experience.
• Broad experience with in vitro and in vivo preclinical assays and their application to predict human ADME and potential DDI.
• Ability to collaborate on the discovery of clinical leads, and the preclinical characterization of leads to identify clinical candidates
• Experience with IND filings
• Strong communication skills, with the ability to work on fast-moving, collaborative, cross-functional teams

Volastra is a lean team of dedicated individuals working to advance therapies for patients with metastatic cancer.  As such, the Associate Director/Director/Senior Director of DMPK will from time to time have the opportunity to work on projects and take on responsibilities that may fall outside his/her scope of work.