Distinguished Scientist, Pharmacokinetics

About the role

The Distinguished Scientist will lead DMPK submission strategy across therapeutic areas, ensuring robust non‑clinical pharmacokinetic packages from first‑in‑human through marketing applications and lifecycle management.

Key responsibilities

• Monitor late‑stage and post‑marketing programs to deliver timely, high‑quality nonclinical PK packages for original and supplemental marketing applications.
• Represent PDMB in label‑approval strategy teams and ad‑hoc discussions, providing DMPK expertise for clinical safety, risk management and regulatory filings.
• Review investigator brochures, INDs, NDAs, regulatory responses and other scientific documents supporting global trials and registrations.
• Provide scientific oversight for development candidates, collaborating with cross‑functional partners to align regulatory strategy and mechanistic investigations.
• Contribute to clinical pharmacology strategy for Phase 1 studies, including dose selection, escalation, drug‑interaction and special‑population assessments.
• Lead initiatives to improve policies, procedures and strategic direction in line with portfolio and regulatory expectations.
• Oversee due‑diligence reviews for in‑licensing assets and serve as integration lead for high‑priority programs.

Required profile

• PhD or M.Sci. in Pharmaceutical Sciences, Pharmacology or related field.
• Minimum 15 years of DMPK experience with a track record of supporting clinical candidates and first‑in‑human studies.
• Strong scientific acumen and deep understanding of drug development processes and regulatory guidelines.
• Proven leadership, collaboration and influence across multidisciplinary scientific teams.
• Excellent organizational, verbal and written communication skills.

Required skills

• Drug Metabolism and Pharmacokinetics (DMPK)
• Regulatory submissions and filing strategies
• Nonclinical PK package development
• Scientific leadership and portfolio strategy
• Small‑molecule drug development