Tech Stack

Description

You will lead the DMPK strategy across the company, overseeing studies to support discovery, development, and regulatory filings. You'll build and guide a high-performing team, collaborate cross-functionally, and ensure high-quality data for IND, CTA, and NDA submissions. This is a pivotal role in a fast-growing biotech preparing for its first commercial launch.

Requirements

• 12+ years of industry experience in DMPK including leadership responsibility
• PhD in Pharmaceutical Sciences, Pharmacokinetics, Biochemistry, Chemistry, or related discipline
• Proven track record supporting programs from discovery through clinical development
• Hands-on expertise with ADME assays, mechanistic metabolism studies, and PK/PD modeling
• Experience with small-molecule oncology therapeutics preferred

Responsibilities

• Provide scientific leadership for all DMPK activities across discovery, preclinical, and development-stage programs
• Develop and execute DMPK strategies including ADME, bioanalysis, PK/PD modeling, and metabolism studies
• Serve as primary DMPK representative on program teams influencing strategy and decision-making
• Oversee design, outsourcing, and interpretation of ADME, PK, TK, and metabolism studies under GLP and non-GLP conditions
• Author and review DMPK sections of regulatory submissions (IND/CTA, IB, briefing packages, NDAs/MAAs)