Clinical Pharmacology Lead - PK/PD & Study Design

SK Life Science; Paramus (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

SK Life Science, Paramus, NJ, seeks an Associate Director, Clinical Pharmacology to lead PK/PD study design, execution and interpretation. You will guide Phase 1 CRO selection and ensure CP plans support dose selection for Phases 1–3, presenting PK/PD data to internal teams and collaborators.

The role may mentor staff, contribute to regulatory filings, and serve as CP lead on multiple programs. Requires a PhD or PharmD with 7+ years in PK/PD, and strong writing and collaboration skills in a

Qualifications

• PhD or PharmD in Pharmaceutical Sciences or related field.
• 7+ years in industry with PK/PD expertise.
• Leadership of CP programs.
• Strong PK/PD modeling and data analysis skills.
• Experience with NONMEM or population PK.
• Excellent written and verbal communication.
• Ability to work in a matrix environment.

Responsibilities

• Act as CP representative on multidisciplinary study teams.
• Design and interpret Phase 1 PK/PD studies.
• Perform non-compartmental and PK/PD modeling analyses.
• Contribute to study protocol design and reports.
• Assist in CRO selection for CP programs.
• Support dose selection for Phase 1–3.
• Collaborate on regulatory filings with cross-functional teams.
• Mentor staff and provide CP expertise.
• Lead CP-related components in regulatory documents.
• Lead CP studies for Clinical Pharmacology Phase 1.

Skills

PK/PD expertise

Leadership of CP programs

Non-compartmental analysis

Population PK modeling

NONMEM knowledge

R programming

Regulatory writing

Communication skills

Matrix environment

Independent worker

Education

PhD or PharmD in Pharmaceutical Sciences

Tools

NONMEM

R

Job description

SK Life Science, Paramus, NJ, seeks an Associate Director, Clinical Pharmacology to lead PK/PD study design, execution and interpretation. You will guide Phase 1 CRO selection and ensure CP plans support dose selection for Phases 1–3, presenting PK/PD data to internal teams and collaborators.

The role may mentor staff, contribute to regulatory filings, and serve as CP lead on multiple programs. Requires a PhD or PharmD with 7+ years in PK/PD, and strong writing and collaboration skills in a