Executive Director, Clinical Pharmacology & Immunogenicity

ClinLab Solutions Group; Lexington (MA); On-site; USD 190,000 - 270,000; Full time

Job summary

ClinLab Solutions Group in Lexington, MA seeks a senior leader to build its internal Clinical Pharmacology function, bringing PK/PD and ADA data to the fore and guiding regulatory strategy for biologics from preclinical to IND and beyond.

The role requires a PhD in Clinical Pharmacology (or MD/PharmD) with 12+ years of program leadership, deep biologics experience, and strong cross-functional collaboration skills to partner with development, regulatory, and biometrics teams.

Qualifications

• PhD in Clinical Pharmacology or MD/PharmD with relevant experience; 12+ years of progressive leadership.
• Strong hands-on experience with clinical and non-clinical PK/PD data interpretation and immunogenicity assessment.
• Experience leading biologics programs across early to late-stage development and regulatory submissions.

Responsibilities

• Provide strategic leadership in PK/PD and ADA data analysis across the portfolio.
• Guide dose selection, trial design, and regulatory strategy for biologics from preclinical to IND and beyond.
• Lead PK/ADA data interpretation across animal and human studies; integrate findings for decision-making.
• Author regulatory sections and collaborate cross-functionally with development, biometrics, and regulatory affairs.
• Define and build internal clinical pharmacology capabilities in partnership with external consultants during transition.

Skills

Clinical pharmacology

PK/PD analysis

Immunogenicity ADA/NAb

Biologics development

Regulatory strategy

Leadership

Executive communication

Education

PhD in Clinical Pharmacology

MD or PharmD with relevant experience

Job description

ClinLab Solutions Group in Lexington, MA seeks a senior leader to build its internal Clinical Pharmacology function, bringing PK/PD and ADA data to the fore and guiding regulatory strategy for biologics from preclinical to IND and beyond.

The role requires a PhD in Clinical Pharmacology (or MD/PharmD) with 12+ years of program leadership, deep biologics experience, and strong cross-functional collaboration skills to partner with development, regulatory, and biometrics teams.