Director, Clinical Pharmacology & PK-PD Strategy

CSL; Waltham (MA); Hybrid; USD 240,000 - 275,000; Full time

Job summary

CSL is seeking a Director of Clinical Pharmacology to lead clinical pharmacology strategy across a diverse R&D portfolio. The role emphasizes PK-PD leadership, cross-functional collaboration, and regulatory interactions across programs in a hybrid work environment (onsite in MA or PA or Switzerland).

The candidate will integrate pharmacology strategies into global development plans, guide PK-PD assessments, and apply modeling/simulation to inform dose selection and program decisions.

Qualifications

• Advanced clinical pharmacology knowledge to lead PK-PD strategy across programs.
• Experience with pharmacometricians and cross-functional teams in drug development.
• Strong background in PK, PD, and PK-PD integration for decision making.
• Proven experience supporting regulatory submissions and health authority interactions.

Responsibilities

• Lead clinical pharmacology and PK-PD strategies for assigned programs.
• Design and oversight of clinical pharmacology studies and protocols.
• Plan and perform PK/PD analyses to inform development decisions.
• Interpret study results and ensure high-quality reporting in documents.
• Represent pharmacology on cross-functional development teams and regulatory interactions.
• Apply modeling and simulation to inform dose selection and study design.

Skills

Clinical pharmacology strategy

PK-PD analyses

Modeling & simulation

Regulatory submissions

Cross-functional collaboration

Education

PhD or PharmD in Clinical Pharmacology

Clinical pharmacology fellowship preferred

Job description

CSL is seeking a Director of Clinical Pharmacology to lead clinical pharmacology strategy across a diverse R&D portfolio. The role emphasizes PK-PD leadership, cross-functional collaboration, and regulatory interactions across programs in a hybrid work environment (onsite in MA or PA or Switzerland).

The candidate will integrate pharmacology strategies into global development plans, guide PK-PD assessments, and apply modeling/simulation to inform dose selection and program decisions.