Director DMPK

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

Director DMPK - Permanent, Full time- Bay Area, CA (Hybrid: 2 days onsite / 3 days remote)

Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.

Proclinical is seeking a highly motivated Director, DMPK to join an innovative, clinical‑stage biotechnology environment focused on advancing novel small-molecule therapies for immune‑mediated inflammatory diseases. This is a senior scientific leadership role offering the opportunity to shape DMPK strategy from discovery through clinical development in a fast-paced, collaborative setting.

The Role:

As Director, DMPK, you will provide technical and scientific leadership across discovery and development programs, serving as the DMPK subject matter expert and program lead. You will define and execute ADME, PK, and PK‑PD strategies, support key development decisions, and play a critical role in first‑in‑human dose predictions and regulatory submissions. You will work cross‑functionally with medicinal chemistry, toxicology, pharmacology, CMC, and clinical teams, and manage external partners to ensure high‑quality, timely DMPK execution.

Key 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

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

This role offers a unique opportunity to make a meaningful impact on the development of tansformative therapies while working alongside a passionate, high‑caliber team.