Clinical Pharmacology / Pharmacometrics

Title: Principal / Associate Director
Location: New Jersey (Hybrid)
Therapeutic Area: CNS / Psychiatric

The Clinical Pharmacology / Pharmacometrics leader will be responsible for the design and implementation of quantitative, data-driven modeling and simulation strategies to inform decision-making across all phases of drug development, from early development through late-stage clinical trials.

Responsibilities:

• Generate and interpret pharmacokinetic/pharmacodynamic (PK/PD) models.
• Serve as the lead clinical pharmacologist, identifying necessary studies based on regulatory strategy and overseeing their design and execution.
• Provide clinical input for planning and running Phase 1, 2, and 3 studies.
• Ensure all projects follow Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulatory guidelines. Stay updated on changes to clinical and bioequivalence study guidance.
• Spot gaps in early-stage development that could delay later phases, both for internal projects and those under review for potential partnerships.

Qualifications:

• Masters Degree (Pharmacology, Pharmaceuticals Sciences, or a related field)
• Hands-on experience using PK/PD modeling tools like NONMEM, R, SAS, MATLAB, Phoenix, SimCyp, or GastroPlus.
• Strong knowledge of quantitative pharmacology and experience using modeling and simulation to help choose doses, understand safety, and support product labeling.
• Able to independently plan, organize, and analyze PK/PD data.
• Self-motivated with a strong technical background, able to work well in a fast-paced and innovative environment.
• Excellent problem-solving skills and strong written and verbal communication.