Executive Director, Clinical Pharmacology & Translational Science

AirNexis Therapeutics, Inc.; United States; On-site; USD 300,000 - 520,000; Full time

Job summary

AirNexis Therapeutics, Inc. is seeking an Executive Director, Clinical Pharmacology to provide strategic leadership across development programs, from early studies through regulatory submissions.

This leader will set clinical pharmacology strategies to optimize dose selection and exposure–response relationships, informing product labeling and regulatory strategies. The role reports to the Chief Medical Officer and will coordinate with Clinical Development, Regulatory Affairs, Nonclinical, and

Qualifications

• Ph.D. in Clinical Pharmacology or related field required.
• 15+ years of pharmaceutical/biotech experience.
• Experience leading end-to-end drug development programs and regulatory submissions.
• Experience with regulatory interactions with FDA/EMA/other health authorities.
• Respiratory disease experience preferred.

Responsibilities

• Lead overall clinical pharmacology strategy across development programs.
• Design plans supporting IND, End-of-Phase 2, Phase 3, NDA/MAA, and post-marketing commitments.
• Lead dose selection using PK/PD, exposure–response analyses, and modeling.
• Provide scientific oversight for FIH, SAD/MAD, DDI, QT, organ impairment and population PK studies.
• Ensure clinical pharmacology data supports labeling and regulatory submissions.
• Serve as a strategic leader across end-to-end drug development and governance.
• Collaborate with translational medicine, nonclinical, regulatory, medical writing, CMC, and PM.
• Provide clinical pharmacology input for formulation development.

Skills

Leadership

Clinical pharmacology

Regulatory submissions

Cross-functional leadership

Project management

Education

Ph.D. in Clinical Pharmacology or related field

Job description

AirNexis Therapeutics, Inc. is seeking an Executive Director, Clinical Pharmacology to provide strategic leadership across development programs, from early studies through regulatory submissions.

This leader will set clinical pharmacology strategies to optimize dose selection and exposure–response relationships, informing product labeling and regulatory strategies. The role reports to the Chief Medical Officer and will coordinate with Clinical Development, Regulatory Affairs, Nonclinical, and