Director, Clinical Pharmacology

Princeton, NJ
Full Time
Experienced
Job Summary

The Director of Clinical Pharmacology will lead the design, execution, and analysis of clinical pharmacology studies to support drug development programs. This role requires deep expertise in pharmacokinetics (PK), pharmacodynamics (PD), and regulatory strategy to optimize study design, data interpretation, and regulatory submissions. The successful candidate will be expected to both conduct hands-on PK/PD modeling and simulation and provide strategic leadership across programs. This position will collaborate cross-functionally to advance SystImmune’s pipeline of innovative oncology therapeutics and represent clinical pharmacology in regulatory interactions.

Key Responsibilities
  • Plan and oversee clinical pharmacology studies in collaboration with internal teams and external partners.
  • Conduct hands-on PK/PD modeling and simulation (e.g., Phoenix WinNonlin, NONMEM, R) to guide study design, dosing strategies, and data analysis.
  • Utilize biomarkers and intermediate clinical endpoints to inform dose selection, dose optimization, and efficacy/safety assessments.
  • Author and review clinical study protocols, reports, and regulatory submissions (e.g., INDs, NDAs, BLAs) in compliance with global guidelines (US, EU, China, Japan, etc.).
  • Present clinical pharmacology findings and recommendations to internal teams, regulatory agencies, and external stakeholders.
  • Work closely with preclinical, clinical, regulatory, biostatistics, and medical affairs teams to drive drug development programs.
Qualifications
  • Ph.D., Pharm.D., or M.D. in Clinical Pharmacology or a related field.
  • Minimum 7 years of clinical pharmacology experience in biotech/pharmaceuticals, with a focus on oncology.
  • Familiarity with US, European, and Asian regulatory requirements, with experience supporting regulatory interactions.
  • Proficiency in PK/PD modeling software (e.g., Phoenix WinNonlin, NONMEM, R).
  • Hands-on experience in PK/PD data analysis and interpretation.
  • Track record of authoring clinical protocols, study reports, and regulatory documents.
  • Exceptional communication, presentation, and interpersonal skills.
  • Ability to work independently and collaboratively in a multidisciplinary team.
  • Strong problem-solving skills and ability to meet deadlines in a fast-paced environment.
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