EPM Scientific
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
Referrals increase your chances of interviewing at EPM Scientific by 2x
#J-18808-Ljbffr
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
Referrals increase your chances of interviewing at EPM Scientific by 2x
#J-18808-Ljbffr