Director, DMPK Strategy & PK-PD Leadership

Proclinical; San Francisco (CA); Hybrid; USD 190,000 - 240,000; Full time

Benefits offered by this job

Health, dental, vision

401(k) plan

Parental leave

Job summary

Proclinical seeks a Director, DMPK to lead ADME, PK, and PK‑PD strategies across discovery to clinical development in a biotech setting. You will guide DMPK program design, data interpretation, and regulatory documentation with senior leadership input, while collaborating across multiple functions and external partners.

The role requires a PhD and 6+ years of DMPK experience, strong communication, and a record of shaping translational PK/PD decisions in a fast-paced environment.

Qualifications

• PhD in pharmacokinetics, drug metabolism, or related discipline.
• 6+ years of small-molecule DMPK experience in the pharmaceutical or biotechnology industry.
• Experience with regulatory submissions and interacting with U.S. and international regulatory agencies.
• Hands-on experience analyzing PK and PK‑PD data using relevant software tools.
• Strong understanding of regulatory guidelines supporting small‑molecule drug development.

Responsibilities

• Lead and implement DMPK and PK‑PD strategies aligned with discovery and development objectives.
• Serve as 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 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.

Skills

DMPK leadership

Data analysis

Regulatory communications

Cross-functional collaboration

Scientific leadership

Communication skills

Education

PhD in pharmacokinetics or drug metabolism

Job description

Proclinical seeks a Director, DMPK to lead ADME, PK, and PK‑PD strategies across discovery to clinical development in a biotech setting. You will guide DMPK program design, data interpretation, and regulatory documentation with senior leadership input, while collaborating across multiple functions and external partners.

The role requires a PhD and 6+ years of DMPK experience, strong communication, and a record of shaping translational PK/PD decisions in a fast-paced environment.