Associate Director, Clinical Pharmacology — PK/PD Strategist

SK Life Science, Inc.; Paramus (NJ); In loco; USD 150.000 - 220.000; Tempo pieno

Vantaggi offerti da questo lavoro

401(k) plan with company match

Medical, dental, and vision coverage

Descrizione del lavoro

SK Life Science, Inc. in Paramus, NJ, seeks an Associate Director of Clinical Pharmacology to lead the design, execution, interpretation, and reporting of PK/PD studies across multiple phases.

This role will shape CP strategy, participate in CRO selection for Phase 1 studies, and ensure robust PK/PD data drive dose selection for Phase 1–3 programs, with mentoring responsibilities for junior staff. You will collaborate with cross-functional teams to prepare regulatory filings (INDs, NDAs, IBs),

Competenze

• PhD or PharmD in Pharmaceutical Sciences or related discipline.
• At least 7 years of industry experience with PK/PD focus.
• Experience leading CP programs.
• Strong PK/PD analysis—compartmental and non-compartmental.

Mansioni

• Act as CP representative to multidisciplinary study teams for early and late-stage programs.
• Design and interpret Phase 1 and other PK/PKPD studies.
• Perform non-compartmental PK analysis and PK/PD modeling/simulation.
• Contribute to study protocol design and clinical study reports review.
• Contribute to selection of Phase 1 CROs.
• Participate in dose selection for Phase 1–3 studies.
• Collaborate with preclinical, biostatistics, clinical operations, medical directors, and regulatory affairs.
• Represent CP on multi-disciplinary teams and contribute to regulatory documents as needed.
• Act as Clinical Study Lead for CP/Phase 1 studies.

Conoscenze

PK/PD

Clinical pharmacology

NONMEM

R

PK data analysis

Regulatory writing

Cross-functional collaboration

Formazione

PhD or PharmD

Strumenti

NONMEM

R

Descrizione del lavoro

SK Life Science, Inc. in Paramus, NJ, seeks an Associate Director of Clinical Pharmacology to lead the design, execution, interpretation, and reporting of PK/PD studies across multiple phases.

This role will shape CP strategy, participate in CRO selection for Phase 1 studies, and ensure robust PK/PD data drive dose selection for Phase 1–3 programs, with mentoring responsibilities for junior staff. You will collaborate with cross-functional teams to prepare regulatory filings (INDs, NDAs, IBs),