Director DMPK

Shape the Future of Immune-Mediated Inflammatory Disease Therapies

Join a growing, clinical-stage biotechnology company dedicated to advancing novel small-molecule therapies. This senior scientific leadership position offers the opportunity to define and execute DMPK strategy from discovery through clinical development within a fast-paced, collaborative environment.

Key Responsibilities

• Lead and implement DMPK and PK-PD strategies aligned with discovery and development objectives.
• Serve as the DMPK program lead, responsible for study design, execution, analysis, interpretation, and reporting.
• Provide expert interpretation of DMPK data and present findings to project teams, senior leadership, and external stakeholders.
• Collaborate closely across R&D functions, including medicinal chemistry, toxicology, pharmacology, CMC, and clinical teams, to enable data-driven decision-making.
• Oversee bioanalytical and DMPK studies conducted internally and through CROs.
• Author and review PK/DMPK sections of regulatory documents (IND, IB, CTA, NDA/BLA) and respond to regulatory inquiries.
• Support clinical pharmacology activities, including first-in-human dose projections.
• Maintain high standards of scientific rigor, quality, and documentation.

Qualifications

• PhD in pharmacokinetics, drug metabolism, or a related discipline.
• 6+ years of small-molecule DMPK experience in the pharmaceutical or biotechnology industry.
• Proven track record leading DMPK efforts across discovery and development.
• Experience with clinical candidate selection and translational PK/PD.
• Hands-on experience analyzing PK and PK-PD data using relevant software tools.
• Strong understanding of regulatory guidelines supporting small-molecule drug development.
• Experience preparing regulatory submissions and interacting with U.S. and international regulatory agencies.
• Ability to oversee bioanalytical method development and validation.

Leadership & Skills

• Influential scientific leader with direct accountability for DMPK strategy.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Detail-oriented, adaptable, and comfortable working hands-on in a small, fast-moving organization.

Compensation & Benefits

• Salary: US$190,000 - US$240,000 (commensurate with experience).
• Eligibility for performance-based bonuses and/or equity compensation.
• Comprehensive benefits package including health, dental, vision, 401(k), generous time-off programs, paid parental leave, and additional insurance offerings.