Clinical Pharmacology Lead - PK & Immunogenicity Strategy

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 315,000 - 325,000; Full time

Job summary

Kiniksa Pharmaceuticals is seeking an Executive Director of Clinical Pharmacology in Lexington, MA, to provide strategic leadership in analyzing pharmacokinetic and immunogenicity data. This critical role will guide dose selection and regulatory strategy for biologic therapies.

The ideal candidate will have over 12 years of experience in drug development and regulatory submissions. Strong collaboration across functions is essential, as is expertise in PK analysis and immunogenicity assessment.

Compensation ranges from $315,000 to $325,000 USD.

Qualifications

• 12+ years of progressive experience with demonstrated program leadership.
• Strong understanding of biologic drug disposition and translational PK principles.
• Excellent scientific writing and data communication skills.

Responsibilities

• Provide scientific leadership for clinical pharmacology strategy.
• Lead the analysis and interpretation of PK and ADA data.
• Support clinical PK/ADA sampling strategies.

Skills

Clinical and non‑clinical PK data interpretation

Immunogenicity assessment (ADA/NAb)

Biologic drug development

Regulatory submissions and agency interactions

Scientific writing

Education

PhD in Clinical Pharmacology or related field

Job description

Kiniksa Pharmaceuticals is seeking an Executive Director of Clinical Pharmacology in Lexington, MA, to provide strategic leadership in analyzing pharmacokinetic and immunogenicity data. This critical role will guide dose selection and regulatory strategy for biologic therapies.

The ideal candidate will have over 12 years of experience in drug development and regulatory submissions. Strong collaboration across functions is essential, as is expertise in PK analysis and immunogenicity assessment.

Compensation ranges from $315,000 to $325,000 USD.