Job Description: Director of DMPK

Do you want to grow a company that positively impacts the world? At twoXAR Pharmaceuticals, we discover and develop first-in-class small molecules. We are seeking a DIRECTOR/ DMPK to oversee our DMPK efforts. The role will be involved in the design, execution, analysis, interpretation and communication of PK/ADME studies of small molecules to provide PK/ADME characteristics to support drug development. This position requires strong intellectual leadership, working at the interface of discovery and development teams and will serve as the nonclinical DMPK subject matter expert. This position requires knowledge of PK/PD modeling to support IND-candidate selection and facilitate prediction of exposure required in humans and is critical to our success; rate is commensurate with skills & experience.

twoXAR is an AI-driven drug discovery and development company focused on first-in-class small molecules. The company currently has a development portfolio of over 18 diseases. twoXAR saves years in drug development while generating a 30x hit rate at in vivo efficacy milestones over traditional methods. We have established collaborations with leading biopharmaceutical companies and are now scaling the business and building our internal drug pipeline. twoXAR is venture-backed with financing from SoftBank Ventures and Andreessen Horowitz and has strong ties to Stanford University and MIT. Our management team and advisory board have decades of biopharmaceutical management experience, built software systems used by tens of millions of people, held VP and C-level positions at Fortune 100 companies, and have had previous startups with successful strategic acquisitions.

Responsibilities

• Represent DMPK as the subject matter expert for nonclinical development

• Responsible for the analysis, interpretation, integration and reporting of nonclinical DMPK data generated with external vendors/CROs

• Design preclinical studies and report results to project teams to evaluate and optimize series and compounds towards a selected candidate with acceptable predicted clinical PK properties and drug-drug interaction profile.

• Deliver the preclinical and translational DMPK work package to support projects in lead optimization and clinical candidate selection

• Review and interpret bioanalytic data and reports.

• Perform human PK projection, and contribute to the analysis of preclinical PK/PD data for selection of FIH dose levels

• Collaborate with Clinical Development to characterize human pharmacokinetics, metabolism, and biopharmaceutics of clinical compounds

• Participate in the management of CRO sites in the conduct of in vitro/in vivo ADME and DMPK modeling studies

• Lead and prepare DMPK components of preclinical and clinical study protocol designs, nonclinical and clinical study reports, and investigator brochures.

• Author high quality Regulatory documents including INDs, CTAs, and NDA filings.

• Partner with and support Medicinal Chemistry, Research, Toxicology, Clinical, Regulatory, Project Management and other departments.

• Manage and mentor junior level scientists

Qualifications/Requirements

• Ph.D. or PharmD degree in Pharmacokinetics, Pharmaceutics, or related scientific discipline with at least 14-17 years of experience in the biopharmaceutical industry out of which 8 years of demonstrated success in a management role.

• Strong knowledge of ADME concepts, pharmacokinetic modeling, pharmacodynamic and bioanalytical principles.

• Experience in the early and late stage development of small molecules is desirable

• Working knowledge of pharmacokinetic and other analysis software (e.g. WinNonlin, NONMEM, etc.) and demonstrated ability to plan, organize, and critically assess and/or perform PK/PD data analyses

• Strong communication skills (verbal and written) and presentation skills required. Excellent interpersonal skills

• Good knowledge of current regulatory guidelines

• Demonstrated capability to manage and mentor junior level scientists

• Excellent oral and written communication skills

twoXAR is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.