AVP - Biometrics & Clinical Pharmacology Specialist
Title: Principal / Associate Director
Location: New Jersey (Hybrid)
Therapeutic Area: CNS / Psychiatric
Base pay range
$160,000.00/yr - $175,000.00/yr
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.
Seniority Level
Entry level
Employment Type
Full-time
Job Function
Other
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